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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
288
Double blinded Megestrol Acetate 20 mg/day
Double blinded Megestrol Acetate 40 mg/day
Megestrol Acetate Placebo 20 mg/day
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
Time frame: 3, 6, and 9 months
Document any effects of various dose levels of megestrol acetate on atrophic vaginitis and dyspareunia
Time frame: 3, 6, and 9 months
Evaluate toxicity of two dose levels of megestrol acetate relative to placebo
Time frame: 3, 6, and 9 months
Feasibility of accrual patients to placebo-controlled study
Time frame: At registration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Megestrol Acetate Placebo 40 mg/day