Breast Cancer Clinical Trial
Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
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.
Full 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.
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
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There is 1 Location for this study
Portland Oregon, 97201, United States
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