Trial Outcomes & Findings for Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma (NCT NCT00878995)
NCT ID: NCT00878995
Last Updated: 2018-03-12
Results Overview
Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.
COMPLETED
PHASE1
28 participants
7 weeks
2018-03-12
Participant Flow
Subjects were recruited via UTMB Oncology, Radiation Oncology, and ENT clinics by study physicians.
Subjects began study before beginning chemotherapy and/or radiation therapy. 28 subjects enrolled total. 4 subjects withdrew before beginning the study.
Participant milestones
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Baseline Study - Midpoint Study
STARTED
|
12
|
12
|
|
Baseline Study - Midpoint Study
Baseline Study
|
12
|
12
|
|
Baseline Study - Midpoint Study
COMPLETED
|
12
|
10
|
|
Baseline Study - Midpoint Study
NOT COMPLETED
|
0
|
2
|
|
Midpoint Study - Post Study
STARTED
|
12
|
10
|
|
Midpoint Study - Post Study
COMPLETED
|
12
|
10
|
|
Midpoint Study - Post Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Baseline Study - Midpoint Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
48.66 years
STANDARD_DEVIATION 12.26 • n=7 Participants
|
51.44 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: Reporting data for the 22 completing subjects only, since this data is reported as change over time.
Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=10 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.
|
-3.31 Percent change
Standard Deviation 6.34
|
1.42 Percent change
Standard Deviation 7.25
|
SECONDARY outcome
Timeframe: BaselinePopulation: 24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer.
Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline
|
81.77 Newton-Meters
Standard Deviation 42.58
|
122.50 Newton-Meters
Standard Deviation 70.78
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.
Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=6 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.
|
76.75 Newton-Meters
Standard Deviation 25.22
|
118.26 Newton-Meters
Standard Deviation 62.26
|
SECONDARY outcome
Timeframe: BaselinePopulation: 24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer.
Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.
|
137.60 Watts
Standard Deviation 86.77
|
169.0 Watts
Standard Deviation 99.71
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.
Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=6 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks
|
126.93 Watts
Standard Deviation 57.05
|
157.90 Watts
Standard Deviation 84.49
|
SECONDARY outcome
Timeframe: BaselinePopulation: 24 subjects began the study. Each subjects was able to complete this outcome measure at the baseline time point.
Body weight in kilograms as measured by a scale at the baseline visit.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Body Weight as Measured by Scale at Baseline
|
65.98 Kilograms
Standard Deviation 25.49
|
63.11 Kilograms
Standard Deviation 17.24
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 22 subjects completed this outcome measure at the 7 week time point. 24 subjects started the study, 2 subjects dis-enrolled after the baseline visit.
Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=10 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Body Weight as Measured by Scale at 7 Weeks.
|
63.93 Kilograms
Standard Deviation 24.79
|
62.59 Kilograms
Standard Deviation 17.83
|
SECONDARY outcome
Timeframe: BaselinePopulation: 24 subjects completed this outcome measure at the baseline visit.
Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline
|
1329.20 kilo-calories per day
Standard Deviation 359.94
|
1310.81 kilo-calories per day
Standard Deviation 398.16
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Only 19 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.
Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=10 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks
|
1338.10 kilo-calories per day
Standard Deviation 281.77
|
1260.98 kilo-calories per day
Standard Deviation 222.32
|
SECONDARY outcome
Timeframe: through study completion,up to 7 weeksPopulation: Data from only 12 subjects is presented due to a compliance issue with wearing the activity monitoring belts. A threshold was set to determine if subject was wearing the belt as directed.
Physical activity is reported as % time sedentary for the entire 7 week study.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=3 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Physical Activity Levels as Measured by the ActiGraph Accelerometer
|
73.55 % time sedentary
Standard Deviation 15.78
|
74.74 % time sedentary
Standard Deviation 9.44
|
SECONDARY outcome
Timeframe: BaselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline
|
67.02 picogram/milliliter
Standard Deviation 67.13
|
260.69 picogram/milliliter
Standard Deviation 251.07
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks
|
64.15 picogram/milliliter
Standard Deviation 50.36
|
191.17 picogram/milliliter
Standard Deviation 206.32
|
SECONDARY outcome
Timeframe: baselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.
|
21.62 picogram/milliliter
Standard Deviation 15.61
|
15.71 picogram/milliliter
Standard Deviation 7.89
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks
|
20.63 picogram/milliliter
Standard Deviation 13.01
|
11.66 picogram/milliliter
Standard Deviation 8.17
|
SECONDARY outcome
Timeframe: BaselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.
|
3.11 picogram/milliliter
Standard Deviation 1.95
|
1.98 picogram/milliliter
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.
|
2.13 picogram/milliliter
Standard Deviation 2.02
|
1.71 picogram/milliliter
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: baselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.
|
3.62 picogram/milliliter
Standard Deviation 2.87
|
3.92 picogram/milliliter
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.
|
3.02 picogram/milliliter
Standard Deviation 2.67
|
2.39 picogram/milliliter
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: baselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.
|
4.30 picogram/milliliter
Standard Deviation 4.70
|
3.13 picogram/milliliter
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.
|
10.48 picogram/milliliter
Standard Deviation 24.43
|
2.35 picogram/milliliter
Standard Deviation 2.85
|
SECONDARY outcome
Timeframe: BaselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.
|
3.02 picogram/milliliter
Standard Deviation 2.22
|
14.56 picogram/milliliter
Standard Deviation 26.29
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.
|
3.13 picogram/milliliter
Standard Deviation 1.98
|
12.62 picogram/milliliter
Standard Deviation 24.71
|
SECONDARY outcome
Timeframe: baselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.
|
11.04 picogram/milliliter
Standard Deviation 15.94
|
43.99 picogram/milliliter
Standard Deviation 59.45
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.
|
8.89 picogram/milliliter
Standard Deviation 5.48
|
23.09 picogram/milliliter
Standard Deviation 36.54
|
SECONDARY outcome
Timeframe: BaselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.
|
6.57 picogram/milliliter
Standard Deviation 2.49
|
21.61 picogram/milliliter
Standard Deviation 36.35
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.
|
9.97 picogram/milliliter
Standard Deviation 7.35
|
18.16 picogram/milliliter
Standard Deviation 25.88
|
SECONDARY outcome
Timeframe: BaselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.
|
14.57 picogram/milliliter
Standard Deviation 9.93
|
16.62 picogram/milliliter
Standard Deviation 8.20
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.
|
11.45 picogram/milliliter
Standard Deviation 5.90
|
12.34 picogram/milliliter
Standard Deviation 7.82
|
SECONDARY outcome
Timeframe: baselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.
|
13.35 picogram/milliliter
Standard Deviation 13.99
|
94.52 picogram/milliliter
Standard Deviation 200.92
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks.
|
12.84 picogram/milliliter
Standard Deviation 13.25
|
82.46 picogram/milliliter
Standard Deviation 184.34
|
SECONDARY outcome
Timeframe: BaselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.
|
3.94 picogram/milliliter
Standard Deviation 2.62
|
44.04 picogram/milliliter
Standard Deviation 91.34
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.
|
4.36 picogram/milliliter
Standard Deviation 2.40
|
28.36 picogram/milliliter
Standard Deviation 54.52
|
SECONDARY outcome
Timeframe: BaselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.
|
2.50 picogram/milliliter
Standard Deviation 1.77
|
20.50 picogram/milliliter
Standard Deviation 39.60
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.
|
3.82 picogram/milliliter
Standard Deviation 3.42
|
17.95 picogram/milliliter
Standard Deviation 35.29
|
SECONDARY outcome
Timeframe: baselinePopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.
|
11.87 picogram/milliliter
Standard Deviation 3.02
|
13.88 picogram/milliliter
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Blood was collected for this outcome from only 18 subjects.
Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=7 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks.
|
33.52 picogram/milliliter
Standard Deviation 71.72
|
12.22 picogram/milliliter
Standard Deviation 6.02
|
SECONDARY outcome
Timeframe: baselinePopulation: 24 subjects were able to complete this outcome measure at the baseline study visit.
Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline
|
20513.50 grams
Standard Deviation 13044.73
|
18227.33 grams
Standard Deviation 10470.48
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 24 subjects began the study, 2 were dis-enrolled, 22 subjects finished the study. All 22 subjects completed this outcome measure at 7 weeks.
Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=10 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks
|
17616.58 grams
Standard Deviation 12513.32
|
16776.60 grams
Standard Deviation 10989.56
|
SECONDARY outcome
Timeframe: baselinePopulation: 20 subjects completed this questionnaire at this time point.
The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline
|
47.73 units on a scale
Standard Deviation 27.87
|
52.22 units on a scale
Standard Deviation 23.60
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 21 subjects completed this questionnaire at this time point.
The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=10 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks
|
52.73 Units on a scale
Standard Deviation 22.73
|
46.50 Units on a scale
Standard Deviation 14.54
|
SECONDARY outcome
Timeframe: BaselinePopulation: 21 subjects completed this questionnaire at this time point.
Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=10 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline
|
12.73 Units on a scale
Standard Deviation 25.48
|
21.40 Units on a scale
Standard Deviation 21.27
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 20 subjects completed this questionnaire at this time point.
Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks
|
18.73 Units on a scale
Standard Deviation 24.18
|
26.11 Units on a scale
Standard Deviation 19.73
|
SECONDARY outcome
Timeframe: baselinePopulation: 22 subjects completed this questionnaire at this time point.
Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Mood Measured by Profile of Mood States at Baseline
|
30.73 units on a scale
Standard Deviation 50.67
|
32.55 units on a scale
Standard Deviation 23.74
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 20 subjects completed this questionnaire at this time point.
Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=11 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Mood as Measured by Profile of Mood States at 7 Weeks
|
28.82 Units on a scale
Standard Deviation 44.18
|
35.78 Units on a scale
Standard Deviation 36.81
|
SECONDARY outcome
Timeframe: BaselinePopulation: 19 subjects completed this questionnaire at this time point.
Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=10 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline
|
18.83 scores on a scale
Standard Deviation 3.50
|
30.48 scores on a scale
Standard Deviation 31.63
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 20 subjects completed this questionnaire at this time point.
Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=9 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=10 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks
|
20.11 scores on a scale
Standard Deviation 4.04
|
24.97 scores on a scale
Standard Deviation 20.18
|
SECONDARY outcome
Timeframe: 1 year post studyPopulation: 12 subjects started each group. 2 subjects withdrew after baseline from the testosterone group.
Number of participants who survived one year post study.
Outcome measures
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=12 Participants
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=10 Participants
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
1-year Survival
|
7 Participants
|
6 Participants
|
Adverse Events
Arm I: Standard of Care Therapy + Placebo Testosterone
Arm II: Standard of Care Therapy + Testosterone
Serious adverse events
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=12 participants at risk
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=12 participants at risk
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia Requiring Tranfusion
|
41.7%
5/12 • Number of events 9 • 7 weeks
|
25.0%
3/12 • Number of events 6 • 7 weeks
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
|
Vascular disorders
Cerebrovascular Accident
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
|
General disorders
Anaphylactic shock
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • 7 weeks
|
16.7%
2/12 • Number of events 2 • 7 weeks
|
|
Vascular disorders
Deep Vein Thrombosis
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
|
General disorders
Sycope
|
0.00%
0/12 • 7 weeks
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
Other adverse events
| Measure |
Arm I: Standard of Care Therapy + Placebo Testosterone
n=12 participants at risk
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
|
Arm II: Standard of Care Therapy + Testosterone
n=12 participants at risk
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
|
|---|---|---|
|
General disorders
Dysphagia
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
|
Infections and infestations
Fever
|
16.7%
2/12 • Number of events 2 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
|
Infections and infestations
Neutropenic Fever
|
0.00%
0/12 • 7 weeks
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
|
Renal and urinary disorders
Urinary Tract Infection
|
33.3%
4/12 • Number of events 5 • 7 weeks
|
16.7%
2/12 • Number of events 2 • 7 weeks
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
|
Psychiatric disorders
Altered Mental State
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
|
Blood and lymphatic system disorders
Hyponatremia
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
|
Reproductive system and breast disorders
Vesicovaginal Fistula
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
|
Gastrointestinal disorders
Metastatic Bowel Obstruction
|
8.3%
1/12 • Number of events 1 • 7 weeks
|
0.00%
0/12 • 7 weeks
|
Additional Information
Melinda Sheffield-Moore
University of Texas Medical Branch
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place