Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES:Proportion of Patients Who Maintain Weight or Experience Weight Gain. SECONDARY OBJECTIVES:BMI Trends, Caloric Intake, Weight Maintenance Over Time, Toxicity Profile as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oral megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily) daily for 4 weeks. ARM B (control): Patients are observed for weight loss and gain for 4 weeks. After completion of study treatment, patients are followed up for 12 weeks.

Official Title
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A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia

Conditions
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Anorexia, Weight Changes

Intervention / Treatment
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* Drug: megestrol acetate
* Other: clinical observation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Patients receive oral megestrol acetate 1-2 times daily for 4 weeks. | Drug: megestrol acetate<br>* Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day<br>* Other names: Pallace;|
| Active Comparator: Arm B<br>Patients have clinical observation for weight loss and gain for 4 weeks. | Other: clinical observation<br>* No treatment is given.<br>* Other names: observation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Who Maintain Weight or Experience Weight Gain | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI Trends |  | 4 weeks | 
| Caloric Intake |  | 4 weeks | 
| Weight Maintenance Over Time |  | 4 weeks | 
| Toxicity Profile | Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0 | 4 weeks |