S9626: Megestrol in Treating Hot Flashes Following Treatment for Breast Cancer
|ClinicalTrials.gov Identifier: NCT00005975|
Recruitment Status : Completed
First Posted : June 28, 2004
Last Update Posted : November 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Hot Flashes||Drug: Megestrol Acetate 20mg/day Drug: Megestrol Acetate 40 mg/day Drug: Megestrol Acetate Placebo 20 mg/day Drug: Megestrol Acetate Placebo 40 mg/day||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||April 1998|
|Primary Completion Date :||September 2001|
|Study Completion Date :||March 2002|
Active Comparator: Megestrol Acetate/Placebo 20 mg/day
Double blinded Megestrol Acetate 20 mg/day or Megestrol Acetate Placebo 20 mg/day taken for 3 months
Drug: Megestrol Acetate 20mg/day
Double blinded Megestrol Acetate 20 mg/day
Other Name: NSC-71423Drug: Megestrol Acetate Placebo 20 mg/day
Megestrol Acetate Placebo 20 mg/day
Other Name: NSC-71423
Active Comparator: Megestrol Acetate/Placebo 40 mg/day
Double blinded Megestrol Acetate 40 mg/day or Megestrol Acetate Placebo 40 mg/day taken for 3 months
Drug: Megestrol Acetate 40 mg/day
Double blinded Megestrol Acetate 40 mg/day
Other Name: NSC-71423Drug: Megestrol Acetate Placebo 40 mg/day
Megestrol Acetate Placebo 40 mg/day
Other Name: NSC-71423
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005975
|Study Chair:||John W. Goodwin, MD||Cancer Research for the Ozarks|