Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Menopausal Symptoms; Osteoporosis; Quality of Life
Intervention: raloxifene (Drug); quality-of-life assessment (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Oregon Health and Science University Cancer Institute Official(s) and/or principal investigator(s):
Anna Schwartz, FNP, PhD, Study Chair, Affiliation: Oregon Health and Science University Cancer Institute
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.
Clinical Details
Official title: Breast Cancer Survivors: Exercise and Raloxifene
Study design: Supportive Care, Randomized, Placebo Control
Detailed 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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Oregon Cancer Center, Portland, Oregon 97201-3098, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2001
Last updated: May 23, 2008
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