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

Not Applicable

Completed

• Conditions: Breast Cancer; Menopausal Symptoms; Osteoporosis

• Registration Number: NCT00031811
• Lead Sponsor: OHSU Knight Cancer Institute

Brief 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.

Detailed 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 Timeline

• Study Start: 2001-03
• Study First Submitted: 2002-03-08
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Study First Submitted QC: 2003-08-05
• Study First Posted: 2003-08-06
• Status Verified: 2010-06
• Last Update Submitted: 2012-05-24
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States