Status:
TERMINATED
Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anorexia
Weight Changes
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
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 pati...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01200602
Start Date
March 1 2011
End Date
January 1 2012
Last Update
November 25 2015
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905