Breast Cancer Survivors: Exercise and Raloxifene
N/A
N/A
Female
Breast Cancer, Menopausal Symptoms, Osteoporosis
Trial Information
Breast Cancer Survivors: Exercise and Raloxifene
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
Anna Schwartz, FNP, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000069229
NCT ID:
NCT00031811
Start Date:
March 2001
Completion Date:
April 2003
Related Keywords:
- Breast Cancer
- Menopausal Symptoms
- Osteoporosis
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- osteoporosis
- menopausal symptoms
- Breast Neoplasms
- Osteoporosis
Name | Location |
|---|---|
| OHSU Knight Cancer Institute | Portland, Oregon 97239 |
