Official Title: “Breast Cancer Survivors: Exercise and Raloxifene”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Placebo Control

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.

Intervention(s) in this Clinical Trial

• Drug: raloxifene
• Procedure: quality-of-life assessment

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Oregon Health and Science University Cancer Institute

Overall Clinical Trial Officials and Contacts

Anna Schwartz, FNP, PhD Study Chair Oregon Health and Science University Cancer Institute  

Information obtained from ClinicalTrials.gov on January 06, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00031811

Study ID Number: CDR0000069229

ClinicalTrials.gov Identifier: NCT00031811

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database