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

OHSU Knight Cancer Institute80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Enrollment

Conditions

Breast Cancer Menopausal Symptoms Osteoporosis

Interventions

raloxifeneDRUG

quality-of-life assessmentPROCEDURE

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

Data from ClinicalTrials.gov

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