Clinical trial NCT01200602: Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
Official title: A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anorexia
Weight Changes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-09-13
Enrollment: 1
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 patients with malignancies who are undergoing radiation therapy and/or chemotherapy.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of Patients Who Maintain Weight or Experience Weight Gain
timeFrame: 4 weeks
Secondary outcomes:
measure: BMI Trends
timeFrame: 4 weeks
measure: Caloric Intake
timeFrame: 4 weeks
measure: Weight Maintenance Over Time
timeFrame: 4 weeks
measure: Toxicity Profile
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vilmarie Rodriguez, M.D.
role: STUDY_CHAIR
References: