Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previousl… (NCT00031811) | Clinical Trial Compass
CompletedNot Applicable
Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
United States80 participantsStarted 2001-03
Plain-language 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.
Who can participate
SexFEMALE
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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 dis…