Trial Outcomes & Findings for A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer (NCT NCT01746043)
NCT ID: NCT01746043
Last Updated: 2018-06-06
Results Overview
Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Baseline, 6 weeks
Results posted on
2018-06-06
Participant Flow
Recruitment period: February 25, 2013 to January 5, 2017. All recruitment done at The University of Texas MD Anderson Cancer Center.
Of the 22 participants enrolled 1 participant were excluded from the study before assignment to groups: Of the 21 randomized patients, 19 (90%) were evaluable for the primary efficacy analysis.
Participant milestones
| Measure |
Armodafinil + Placebo
Armodafinil 150mg once a day during the entire course of radiation (6 weeks + 5 days).
|
Minocycline + Placebo
Minocycline 100mg twice a day during the entire course of radiation therapy (6 weeks + 5 days)
|
Armodafinil + Minocycline
Armodafinil (150 mg once a day for 6 weeks) + Minocycline (100 mg twice a day for 6 weeks).
|
Placebo
Matching Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Armodafinil + Placebo
n=5 Participants
Armodafinil 150mg once a day during the entire course of radiation (6 weeks + 5 days)
|
Minocycline + Placebo
n=4 Participants
Minocycline 100mg twice a day during the entire course of radiation therapy (6 weeks + 5 days)
|
Armodafinil + Minocycline
n=5 Participants
Armodafinil (150 mg once a day for 6 weeks) + Minocycline (100 mg twice a day for 6 weeks).
|
Placebo
n=5 Participants
Matching Placebo
|
Total
n=19 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 0.6 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 4.9 • n=4 Participants
|
61.4 years
STANDARD_DEVIATION 5.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeksPopulation: Of the 21 randomized patients , 19 (90% were evaluable for the primary efficacy analysis).
Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores
Outcome measures
| Measure |
Armodafinil + Placebo
n=5 Participants
Armodafinil 150mg once a day during the entire course of radiation (6 weeks + 5 days)
|
Minocycline + Placebo
n=4 Participants
Minocycline 100mg twice a day during the entire course of radiation therapy (6 weeks + 5 days)
|
Armodafinil + Minocycline
n=5 Participants
Armodafinil (150mg once a day) + Minocycline (100mg once a day)
|
Placebos
n=5 Participants
Matching Placebo
|
|---|---|---|---|---|
|
Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Armodafinil
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Minocycline
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Armodafinil+Minocycline
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Armodafinil
n=5 participants at risk
Armodafinil 150 mg once a day during the entire course of chemoXRT (6 weeks + 5 days) or a total of 6 weeks.
|
Minocycline
n=4 participants at risk
Minocycline 100 mg twice a day during the entire course of chemoXT ( 6 weeks + 5 days)
|
Armodafinil+Minocycline
n=5 participants at risk
Armodafinil + Minocycline
|
Placebo
n=5 participants at risk
Matching Placebo
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Fever
|
0.00%
0/5
|
25.0%
1/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Nervous system disorders
Peripheral Neuropathy
|
0.00%
0/5
|
0.00%
0/4
|
20.0%
1/5
|
0.00%
0/5
|
|
Nervous system disorders
Headache
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5
|
Other adverse events
Adverse event data not reported
Additional Information
Lin,Steven H,M.D. Ph.D. / Radiation Oncology
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place