Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer

Breast Cancer Clinical Trial

Official title: Breast Cancer Survivors: Exercise and Raloxifene

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

OBJECTIVES:

• 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. ;

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Menopausal Symptoms
• Osteoporosis

• NCT number: NCT00031811
• Study type: Interventional
• Source: OHSU Knight Cancer Institute
• Status: Completed
• Phase: N/A
• Start date: March 2001
• Completion date: April 2003