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
- 1
- 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
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Diagnosis of primary breast cancer
- •Newly diagnosed stage I or II disease
- •Receiving care at a participating Fox Chase Cancer Center CCOP Research Base (FCRB) member site
- •Geisinger Clinic and Medical Center (phase I)
- •Main Line Health (phase I)
- •Any of the other participating FCRB member sites (phase II)
- •Study intervention is scheduled to begin anytime after surgery up to 3 months after completion of adjuvant chemotherapy
- •Treatment plan includes adjuvant chemotherapy
- •Hormone receptor status not specified
排除标准
- •Treatment plan includes trastuzumab (Herceptin®) or bevacizumab
- •Recurrent breast cancer
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •Premenopausal or postmenopausal
- •Has obtained medical clearance by oncologist and breast surgeon to participate in this study
- •Body mass index ≥ 20 kg/m^2 and < 39 kg/m^2
- •Exclusion criteria:
- •Hemoglobin < 12 g/dL
- •ANC < 1,500/mm^3
- •Any medical condition that restricts participation in a physical activity program (e.g., exercise-induced angina, uncontrolled hypertension, dementia, or a major psychological problem)
- •Answers "yes" to any questions on the Physical Activity Readiness Questionnaire (PAR-Q) and PAR-Q not reviewed by a physician who subsequently approves participation in the physical activity intervention
- •Known to be pregnant or breastfeeding
- •Unwilling to commit or unable to participate in a 6-month physical activity intervention (unable to exercise, usually travels away from home overnight more than once per week, and/or has plans to be away from home for more than two weeks in the next 6 months)
- •Previously diagnosed with another primary cancer other than basal cell or squamous cell carcinoma of the skin
- •Exercising regularly prior to intervention (i.e., reports current participation in vigorous or moderate activity at least 3 days per week for at least 30 minutes each day on the International Physical Activity Questionnaire)
- •Unable to speak and read English
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No neoadjuvant chemotherapy
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 (1)
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