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

Mayo Clinic

Status and phase: Terminated; Phase 2

Conditions: Anorexia; Weight Changes

Treatments: Other: clinical observation; Drug: megestrol acetate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01200602

09-007533 (Other Identifier)

NCI-2010-01938 (Registry Identifier)

MC0896 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Arm A

Experimental group

Description:

Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.

Treatment:

Drug: megestrol acetate

Arm B

Active Comparator group

Description:

Patients have clinical observation for weight loss and gain for 4 weeks.

Treatment:

Other: clinical observation