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

Phase 2
21 Years
Not Enrolling
Anorexia, Weight Changes

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Trial Information

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

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.

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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Proportion of Patients Who Maintain Weight or Experience Weight Gain

Outcome Description:

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 Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Vilmarie Rodriguez, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

January 2012

Related Keywords:

  • Anorexia
  • Weight Changes
  • Anorexia
  • Body Weight Changes
  • Weight Loss



Mayo ClinicRochester, Minnesota  55905