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Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer Clinical research trials and Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer. Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer  Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
For Condition: stage 3B breast cancer,stage 3A breast cancer,Osteoporosis,menopausal symptoms,Quality of Life,stage 1 breast cancer,stage 2 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Oregon Health and Science University
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Determine the effects of these regimens on the quality of life of these patients. PROTOCOL 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:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnaSchwartz, Study Chair, Oregon Health and Science University
Oregon Cancer Center
Portland, Oregon, 97201-3098
United States
Additional Information:
Study ID Numbers: CDR0000069229; NCI-H02-0086,OHSU-6312
Study Start Date: March 2001
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031811
Other Osteoporosis Studies:
1. Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
2. Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer
3. Doxorubicin and Cyclophosphamide Plus Paclitxael With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2
4. Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer
5. Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
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Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
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