Trial Outcomes & Findings for Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy (NCT NCT01200602)
NCT ID: NCT01200602
Last Updated: 2015-11-25
Results Overview
A patient will be defined as "success" if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.
TERMINATED
PHASE2
1 participants
4 weeks
2015-11-25
Participant Flow
One patient was accrued between March 2, 2011 and January 10, 2012. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Participant milestones
| Measure |
Arm A
Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
|
Arm B
Patients have clinical observation for weight loss and gain for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 4 weeksPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
A patient will be defined as "success" if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0
Outcome measures
Outcome data not reported
Adverse Events
Arm A
Arm B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place