Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
RATIONALE: Raloxifene and exercise may improve bone health and quality of life in breast cancer survivors. Assessing bone health and quality of life may improve the ability to plan treatment.
PURPOSE: Randomized clinical trial to study the effectiveness of raloxifene with or without exercise compared with exercise alone in women who have been previously treated for breast cancer.
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Breast Cancer Survivors: Exercise and Raloxifene|
|Study Start Date:||March 2001|
|Study Completion Date:||April 2003|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
- Determine the effects of raloxifene with or without exercise versus exercise alone on bone reabsorption rate, bone formation rate, and bone density in women previously treated for breast cancer.
- Determine the effects of these regimens on the quality of life of these patients.
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are randomized to one of four treatment arms.
- Arm I: Patients are asked to exercise 5 days a week with instruction. Patients also receive oral placebo once daily.
- Arm II: Patients receive oral raloxifene once daily.
- Arm III: Patients are asked to exercise as in arm I. Patients also receive oral raloxifene once daily.
- Arm IV: Patients receive oral placebo once daily. All patients receive oral calcium supplements once daily. Treatment continues in all arms for 24 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and every 3 months during study.
PROJECTED ACCRUAL: A total of 240 patients (60 per treatment arm) will be accrued for this study.
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97201-3098|
|Study Chair:||Anna Schwartz, FNP, PhD||OHSU Knight Cancer Institute|