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

Anorexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01200602
• Other study ID #: MC0896
• Secondary ID: NCI-2010-0193809
• Status: Terminated
• Phase: Phase 2
• First received: September 10, 2010
• Last updated: October 29, 2015
• Start date: March 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Anorexia
• Body Weight Changes
• Weight Changes

Intervention

Drug:
• megestrol acetate
Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day

Other:
• clinical observation
No treatment is given.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	BMI Trends		4 weeks	No
Secondary	Caloric Intake		4 weeks	No
Secondary	Weight Maintenance Over Time		4 weeks	No
Secondary	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	Yes