Evaluating the Feasibility of Pedaling at a Low-moderate Intensity During Chemotherapy Infusions in Colorectal Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility of Pedaling Concurrent to Chemotherapy Infusion
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of completing a low-moderate intensity pedaling session concurrent to chemotherapy treatment for colorectal cancer. Secondary objectives for this study consist of evaluating the role of pedaling on sarcopenia rates, quality of life markers, chemotherapy side effects, rate of hospital admissions, and treatment delays.
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
- 是
入选标准
- •Patients with diagnosed colon or rectal cancer with previous surgical intervention and planned intravenous chemotherapy treatment (FOLFOX or FOLFIRI).
- •ECOG Performance Status of Grade 0-2.
排除标准
- •Limited functional status, demonstrated by an ECOG Performance Status of Grade 3-
- •Severe cardiac history or comorbidities (i.e. have a cardiac defibrillator or have a history of heart failure, clinically significant aortic stenosis, cardiac arrest, uncontrolled angina, uncontrolled arrhythmias, major heart surgery, stroke, or pulmonary embolus).
- •Chest pain or severe shortness of breath at rest or with physical activity.
- •Orthopedic impediments to exercise (i.e. joint immobility or lower extremity lymphedema).
- •Limitations to sustained exercise (i.e. bone metastases in the femur neck).
- •Severe arthritis (i.e. osteoarthritis or rheumatoid arthritis).
研究组 & 干预措施
Pedaling Group
During the first 2 hours of their chemotherapy infusions, participants will pedaling for 30 minutes using a stationary cycle ergometer. Participants will be allowed to determine their pedaling intensity and cadence, however, will be encouraged to reach the established goal intensity level. Additionally, subjects will complete both a physical activity questionnaire (International Physical Activity Questionnaire) and a quality of life questionnaire (European Organization for Research and Treatment of Cancer QLQ - CR 29) at baseline and following their last chemotherapy treatment. A questionnaire on chemotherapy side effects (Memorial Symptom Assessment Scale) will be gathered at baseline, during chemotherapy cycles 3, 6, and/or 12, and following completion of chemotherapy treatment. Lastly, muscular strength and physical performance will be measured via grip strength tests and TGUG tests within 2-4 weeks of the post-surgery and chemotherapy completion CT scans.
干预措施: Pedaling (Behavioral)
结局指标
主要结局
Feasibility of Pedaling Concurrent to Chemotherapy Infusion
时间窗: 12-24 weeks
The number of completed pedaling sessions as well as the ability of patients to meet goal pedaling intensities will be evaluated.
次要结局
- Hospital Admission Rates(12-24 weeks)
- Quality of Life Scores(12-24 weeks)
- Sarcopenia Rates(12-24 weeks)
- Symptom Severity(12-24 weeks)