NCT00005975

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

A Phase III Trial of Placebo Versus Megestrol Acetate 20 MG/Day Versus Megestrol Acetate 40 MG/Day as Treatment for Symptoms of Ovarian Failure in Women Treated for Breast Cancer: SWOG Study S9626

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Female
• Age: 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Hot Flashes

Interventions

Type	Name	Description
DRUG	Megestrol Acetate 20mg/day	Double blinded Megestrol Acetate 20 mg/day
DRUG	Megestrol Acetate 40 mg/day	Double blinded Megestrol Acetate 40 mg/day
DRUG	Megestrol Acetate Placebo 20 mg/day	Megestrol Acetate Placebo 20 mg/day
DRUG	Megestrol Acetate Placebo 40 mg/day	Megestrol Acetate Placebo 40 mg/day

Timeline

• Start date: 1998-04-01
• Primary completion: 2001-09-01
• Completion: 2002-03-01
• First posted: 2004-06-28
• Last updated: 2015-11-18