Feasibility of a 6-Week Aerobic Exercise Program During Chemotherapy for Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed
研究概览
简要总结
This pilot clinical trial studies how well aerobic exercise works in improving quality of life and health-related outcomes in patients with stage IV colorectal cancer undergoing chemotherapy. Aerobic exercise during chemotherapy may improve quality of life and reduce fatigue and inflammation in the blood related to heart disease and diabetes in patients with stage IV colorectal cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether a 6-week indoor or outdoor aerobic exercise program is feasible in patients with metastatic colorectal cancer (mCRC) undergoing chemotherapy and to explore patient's preferences for indoor versus (vs.) outdoor exercise.
II. To determine the effects of a 6-week indoor or outdoor aerobic exercise program on cancer-related fatigue and quality of life (QOL) in patients with mCRC.
SECONDARY OBJECTIVES:
I. To determine the effects of a 6-week indoor or outdoor aerobic exercise program on body composition (lean body mass, fat mass, body fat percentage [%]) and biomarkers of systemic inflammation (interleukin-6 [IL-6], tumor necrosis factor alpha [TNF-a], C-reactive protein [CRP]) in patients with mCRC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed metastatic (stage IV) colorectal cancer
- •Undergoing chemotherapy (have had 1 or 2 chemotherapy cycles infused at time of data collection; this will allow for any systemic inflammatory changes due to chemotherapy to set in); only patients with 1st or 2nd line therapy will be included
- •Able to initiate a supervised exercise program (free from any CV, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
- •Free from uncontrolled chronic disease including diabetes, hypertension, or thyroid disease
- •Currently participate in less than 60 minutes of physical activity/week
- •Willing to travel to the exercise facility at University of Southern California (USC) (parking fees and public transportation permits will be provided)
- •Speak English or Spanish
排除标准
- •Uncontrolled hypertension or other uncontrolled chronic disease (e.g. diabetes mellitus, thyroid disease, pulmonary disease, etc)
- •Moderate to highly active level of physical activity (e.g. currently participating in > 60 minutes of moderate aerobic activity weekly)
- •Orthopedic or other restrictions or contraindications to exercise
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
研究组 & 干预措施
Supportive Care (aerobic exercise)
Patients undergo aerobic exercise sessions consisting of cycling or walking at a low-moderate intensity and progressing to moderate intensity for 30 minutes 2 times a week for up to 8 weeks.
干预措施: Exercise Intervention (Behavioral)
Supportive Care (aerobic exercise)
Patients undergo aerobic exercise sessions consisting of cycling or walking at a low-moderate intensity and progressing to moderate intensity for 30 minutes 2 times a week for up to 8 weeks.
干预措施: Quality-of-Life Assessment (Other)
Supportive Care (aerobic exercise)
Patients undergo aerobic exercise sessions consisting of cycling or walking at a low-moderate intensity and progressing to moderate intensity for 30 minutes 2 times a week for up to 8 weeks.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed
时间窗: Up to 6 weeks
The study will assess the feasibility using average weekly minutes of exercise completion (minutes/week) of all participants. Feasibility will be determined based on the total number of minutes exercised per week with \>80% total weekly minutes (48/60 minutes) completed deeming this trial as feasible.
次要结局
- Change in biomarkers of systemic inflammation(Baseline up to 31 weeks)
- Change in cancer-related fatigue(Baseline up to 31 weeks)
- Change in QOL(Baseline up to 31 weeks)