NCT00509626已完成1 期
A Physical Activity Intervention to Prevent Weight Gain in Breast Cancer Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Accrual (phase I)
研究概览
简要总结
RATIONALE: Physical activity may prevent or reduce weight gain in women receiving chemotherapy for early stage breast cancer.
PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it works compared with usual care to prevent or reduce weight gain in women with stage I or stage II breast cancer undergoing chemotherapy.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility for conducting a clinical trial that uses a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer and prior to initiation of adjuvant chemotherapy, hormonal therapy, and/or radiotherapy. (phase I)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases weight gain in patients treated with adjuvant chemotherapy. (phase II)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects weight change in women who are premenopausal compared to those who are postmenopausal at diagnosis. (phase II)
Secondary
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases gains in adiposity in patients treated with adjuvant chemotherapy. (phase II)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects change in adiposity among women who are premenopausal compared to those who are postmenopausal at diagnosis. (phase II)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases the frequency of depressive symptomology and improves quality of life among patients treated with adjuvant chemotherapy. (phase II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Accrual (phase I)
Retention (phase I)
Weight change after 6 months (phase II)
次要结局
- Adiposity as measured by waist circumference at 3 and 6 months
- Health-related quality of life as measured by the Short-Form Health Survey-12 Physical and Mental Component Summary scales
- Depressive symptomology as measured by the Center for Epidemiologic Studies Depression Scale
研究者
研究点 (2)
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