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

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Raloxifene Hydrochloride

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