Clinical trial · Interventional
Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia
NCT01200602CI-TRIAL-00019933terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study closed due to slow accrual.
Summary
Brief summary (as posted)
RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia | — | UNRESOLVED | — |
| Weight Changes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clinical observation | Other | — | UNRESOLVED |
| megestrol acetate | Drug | Megestrol | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
- interventionNames
- Drug: megestrol acetate
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Patients have clinical observation for weight loss and gain for 4 weeks.
- interventionNames
- Other: clinical observation
Primary outcomes (1)
- measure
- Proportion of Patients Who Maintain Weight or Experience Weight Gain
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Any pediatric patient with an underlying diagnosis of a malignancy (excluding hematological malignancies like leukemias and lymphomas) * ≥5% weight loss from diagnosis of primary malignancy (must be currently on chemotherapy and/or radiation therapy or scheduled to receive cancer therapy OR ≥5% weight loss following bone marrow transplant (autologous or allogeneic blood/bone marrow) and not actively receiving corticosteroid therapy * Negative pregnancy test done =\< 7 days prior to registration for women of childbearing potential only Exclusion Criteria: * Receiving tube feedings or parenteral nutrition * Evidence of ascites * Current (within the past 28 days) or planned treatment with adrenal steroids (short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis), androgens, progestational agents, or appetite stimulants (e.g., dronabinol) * Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (\> 5 episodes/week) * History of unresectable brain tumor or cancer metastatic to the brain * History of thromboembolic disease * Insulin-requiring diabetes * Congestive heart failure and/or uncontrolled hypertension * Anticoagulation * Previous history of thrombosis (personal and immediate family) * Concurrent corticosteroid therapy (except as an antiemetic)
References
Publications (0)
Data not yet available
No reference posted for this study.