NCT00031811已完成不适用
Breast Cancer Survivors: Exercise and Raloxifene
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •Not specified
- •Not specified
- •Cardiovascular:
- •No cardiac problems that would preclude exercise
- •No unstable angina
- •No respiratory problems that would preclude exercise
- •No chronic obstructive pulmonary disease
- •No oxygen dependence
- •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
- •Not specified
- •No concurrent bisphosphonates
排除标准
- 未提供
研究者
研究点 (1)
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