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

Study Overview
=================
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.

Official Title
-----------------
Breast Cancer Survivors: Exercise and Raloxifene

Conditions
-----------------
Breast Cancer, Menopausal Symptoms, Osteoporosis

Intervention / Treatment
-----------------
* Drug: raloxifene
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer No metastatic disease At least 3 months but no more than 1 year since prior chemotherapy regimen including doxorubicin or methotrexate and catabolic steroids (to prevent nausea, vomiting, fluid retention, or hypersensitivity reactions) No routine of regular strenuous exercise (more than 90 minutes per day 6 days/week OR 120 minutes per day 4 days/week) Hormone receptor status: Estrogen and progesterone receptor negative OR Estrogen and progesterone receptor positive PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Postmenopausal (at diagnosis OR chemotherapy-induced) No spontaneous menses for more than 6 months with increased follicle-stimulating hormone and decreased estradiol Performance status: Ambulatory Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No cardiac problems that would preclude exercise No unstable angina Pulmonary: No respiratory problems that would preclude exercise No chronic obstructive pulmonary disease No oxygen dependence Other: No endocrine disease (e.g., parathyroid hormone disorders) that would accelerate bone turnover and loss No musculoskeletal problems or other disease that would preclude exercise (e.g., movement-limiting arthritis, muscular dystrophy, or chronic fatigue syndrome) No known cognitive or psychiatric disorders that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior adjuvant or neoadjuvant chemotherapy allowed No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent tamoxifen Radiotherapy: Prior adjuvant radiotherapy after chemotherapy allowed No concurrent radiotherapy Surgery: Not specified Other: No concurrent bisphosphonates
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: raloxifene|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, osteoporosis, menopausal symptoms