Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
- Conditions
- Hot FlashesBreast CancerMenopausal Symptoms
- Registration Number
- NCT00026286
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Hormone replacement therapy may be effective in managing the hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.
- Detailed Description
OBJECTIVES:
* Determine the efficacy of hormone replacement therapy in managing hot flashes and menopausal vaginal symptoms in postmenopausal women with a history of node-negative invasive carcinoma or ductal carcinoma in situ of the breast who are receiving adjuvant tamoxifen.
* Determine the effect of this regimen on blood coagulation and lipid profiles in these patients.
* Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior hysterectomy (yes vs no), symptom complex (vasomotor vs vaginal vs both), duration of hot flashes (less than 1 year or no hot flashes vs 1 year or more), and average daily number of hot flashes (less than 10 or none vs 10 or more). Patients are randomized to one of two treatment arms.
* Arm I: Patients who have not undergone prior hysterectomy receive oral medroxyprogesterone once daily for 6 months. If, after 1 month, symptoms do not resolve, patients receive oral conjugated estrogens once daily in addition to medroxyprogesterone for 5 months. Patients who have undergone prior hysterectomy receive oral conjugated estrogens once daily for 6 months.
* Arm II: Patients receive oral placebo once daily for 6 months. Quality of life is assessed at baseline and months 1, 2, 3, and 6.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States