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| Sponsor: | Oregon Health and Science University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031811 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Menopausal Symptoms Osteoporosis |
Drug: raloxifene Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Placebo Control |
| Official Title: | Breast Cancer Survivors: Exercise and Raloxifene |
| Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are randomized to one of four treatment arms.
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Oregon | |
| Oregon Cancer Center | |
| Portland, Oregon, United States, 97201-3098 | |
| Study Chair: | Anna Schwartz, FNP, PhD | OHSU Knight Cancer Institute |
More Information
| Study ID Numbers: | CDR0000069229, OHSU-6312, NCI-H02-0086 |
| Study First Received: | March 8, 2002 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00031811 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer osteoporosis menopausal symptoms |
|
Estrogen Antagonists Skin Diseases Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Osteoporosis Bone Density Conservation Agents Bone Diseases, Metabolic |
Selective Estrogen Receptor Modulators Bone Diseases Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Raloxifene Neoplasms by Site Musculoskeletal Diseases Breast Diseases |