Trial Outcomes & Findings for Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy (NCT NCT02012608)
NCT ID: NCT02012608
Last Updated: 2019-05-29
Results Overview
The primary efficacy outcome will be excessive toxicity, which will be defined as a score of 2 or higher using the Radiation Therapy Oncology Group (RTOG) Acute scale of radiation-toxicity criteria when scored on either the 12-day or 30-day assessment time. The RTOG scale ranges from 0-4 with 0 being defined as "no change".
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
12 days and 30 days
Results posted on
2019-05-29
Participant Flow
Participant milestones
| Measure |
Glutamine
Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day
Glutamine: Oral glutamine for subjects undergoing breast conserving therapy
|
Placebo
Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day
Placebo: For subjects undergoing breast conserving therapy
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy
Baseline characteristics by cohort
| Measure |
Glutamine
n=7 Participants
Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day
Glutamine: Oral glutamine for subjects undergoing breast conserving therapy
|
Placebo
n=7 Participants
Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day
Placebo: For subjects undergoing breast conserving therapy
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
PRIMARY outcome
Timeframe: 12 days and 30 daysPopulation: No data displayed because Outcome Measure has zero total participants analyzed and no data was collected.
The primary efficacy outcome will be excessive toxicity, which will be defined as a score of 2 or higher using the Radiation Therapy Oncology Group (RTOG) Acute scale of radiation-toxicity criteria when scored on either the 12-day or 30-day assessment time. The RTOG scale ranges from 0-4 with 0 being defined as "no change".
Outcome measures
Outcome data not reported
Adverse Events
Glutamine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Glutamine
n=7 participants at risk
Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day
Glutamine: Oral glutamine for subjects undergoing breast conserving therapy
|
Placebo
n=7 participants at risk
Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day
Placebo: For subjects undergoing breast conserving therapy
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin hyperpigmentation
|
28.6%
2/7 • Number of events 2 • 3 years
|
28.6%
2/7 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
skin erythema
|
42.9%
3/7 • Number of events 3 • 3 years
|
42.9%
3/7 • Number of events 3 • 3 years
|
|
Blood and lymphatic system disorders
anemia
|
28.6%
2/7 • Number of events 2 • 3 years
|
0.00%
0/7 • 3 years
|
|
Reproductive system and breast disorders
breast pain
|
0.00%
0/7 • 3 years
|
14.3%
1/7 • Number of events 1 • 3 years
|
|
General disorders
fatigue
|
28.6%
2/7 • Number of events 2 • 3 years
|
0.00%
0/7 • 3 years
|
|
Reproductive system and breast disorders
asymptomatic breast edema
|
14.3%
1/7 • Number of events 1 • 3 years
|
0.00%
0/7 • 3 years
|
|
Reproductive system and breast disorders
breast fibrosis/fat necrosis
|
14.3%
1/7 • Number of events 1 • 3 years
|
0.00%
0/7 • 3 years
|
|
Skin and subcutaneous tissue disorders
telangiectasia
|
14.3%
1/7 • Number of events 1 • 3 years
|
0.00%
0/7 • 3 years
|
|
Gastrointestinal disorders
nausea
|
14.3%
1/7 • Number of events 1 • 3 years
|
0.00%
0/7 • 3 years
|
|
Blood and lymphatic system disorders
hyperkalemia
|
0.00%
0/7 • 3 years
|
14.3%
1/7 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
decreased lymphocyte count
|
14.3%
1/7 • Number of events 1 • 3 years
|
0.00%
0/7 • 3 years
|
|
Blood and lymphatic system disorders
increased alkaline phosphatase
|
0.00%
0/7 • 3 years
|
14.3%
1/7 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
chloride out of range
|
0.00%
0/7 • 3 years
|
14.3%
1/7 • Number of events 1 • 3 years
|
Additional Information
Beth Scanlan
University of Arkansas for Medical Sciences
Phone: 501-686-8274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place