S9626: Megestrol in Treating Hot Flashes Following Treatment for Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer; Hot Flashes
• Interventions: Drug: Megestrol Acetate 20mg/day; Drug: Megestrol Acetate 40 mg/day; Drug: Megestrol Acetate Placebo 40 mg/day; Drug: Megestrol Acetate Placebo 20 mg/day

• Registration Number: NCT00005975
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

RATIONALE: Megestrol may be effective in treating hot flashes following treatment for breast cancer. It is not yet known which regimen of megestrol is most effective for hot flashes.

PURPOSE: Randomized phase III trial to compare the effectiveness of different doses of megestrol in treating hot flashes in patients who have undergone therapy for breast cancer.

Detailed Description

OBJECTIVES: I. Compare the effectiveness and duration of the benefit of placebo versus low dose megestrol versus high dose megestrol in the reduction of severe and/or frequent hot flashes in patients with previously treated invasive breast cancer. II. Document the effects of various dose levels of megestrol on atrophic vaginitis and dyspareunia in these patients. III. Evaluate the toxicity of this treatment in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to tamoxifen use (yes vs no), number of hot flashes per week (5-34 vs 35-63 vs more than 63), and duration of hot flashes (6 months or less vs longer than 6 months). Patients are randomized to one of three treatment arms. Arm I: Patients receive oral placebo daily. Arm II: Patients receive lower dose oral megestrol daily. Arm III: Patients receive higher dose oral megestrol daily. Patients who do not respond after 3 months of treatment receive an additional dose of oral megestrol daily. Treatment continues for a total of 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 months.

PROJECTED ACCRUAL: A total of 279 eligible patients (93 per arm) are expected to be accrued.

Study Timeline

• Study Start: 1998-04
• Study First Submitted: 2000-07-05
• Primary Completion: 2001-09
• Study Completion: 2002-03
• Study First Submitted QC: 2004-06-25
• Study First Posted: 2004-06-28
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 288

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Megestrol Acetate/Placebo 20 mg/day	Megestrol Acetate 20mg/day	Double blinded Megestrol Acetate 20 mg/day or Megestrol Acetate Placebo 20 mg/day taken for 3 months
Megestrol Acetate/Placebo 40 mg/day	Megestrol Acetate Placebo 40 mg/day	Double blinded Megestrol Acetate 40 mg/day or Megestrol Acetate Placebo 40 mg/day taken for 3 months
Megestrol Acetate/Placebo 40 mg/day	Megestrol Acetate 40 mg/day	Double blinded Megestrol Acetate 40 mg/day or Megestrol Acetate Placebo 40 mg/day taken for 3 months
Megestrol Acetate/Placebo 20 mg/day	Megestrol Acetate Placebo 20 mg/day	Double blinded Megestrol Acetate 20 mg/day or Megestrol Acetate Placebo 20 mg/day taken for 3 months

Primary Outcome Measures

Name	Time	Method
Effectiveness and duration of the benefit of placebo and 2 dose levels of megestrol acetate in reduction of severe and/or frequent hot flashes in patients with history of adequate local and regional treatment of invasive breast cancer	3, 6, and 9 months

Secondary Outcome Measures

Name	Time	Method
Feasibility of accrual patients to placebo-controlled study	At registration
Evaluate toxicity of two dose levels of megestrol acetate relative to placebo	3, 6, and 9 months
Document any effects of various dose levels of megestrol acetate on atrophic vaginitis and dyspareunia	3, 6, and 9 months