A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Percent of patients screened who are eligible
研究概览
简要总结
This is a feasibility pilot study to initiate a research program to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the hands and feet).
详细描述
This is a feasibility pilot study to help obtain external funding for a larger study to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (CIPN), which is a dose-limiting and painful side effect of chemotherapy for which there are no established treatments. The investigators will conduct a two-arm randomized clinical trial in 40 cancer patients receiving chemotherapy where Arm 1 is 12 weeks of exercise during chemotherapy and Arm 2 is 12 weeks of nutrition education (control condition) during chemotherapy. The investigators will acquire data on CIPN via patient reports and clinical assessments as well as general pain and hypothetical mechanistic factors that may help explain how exercise may treat CIPN; these factors include measures of musculoskeletal, cardiovascular, neuropsychological, and immunological function. The primary outcomes are related to the feasibility of identifying, recruiting, and obtaining complete data from research participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Have non-metastatic cancer
- •Be chemotherapy naïve
- •Be scheduled to receive CIPN-inducing chemotherapy during the study (platinums, vinca alkaloids, taxanes, thalidomide, or bortezomib) for the duration of the intervention (12 weeks)
- •Report symptoms of peripheral neuropathy at baseline (subject-reported severity of numbness and tingling in hands/feet of at least 1 on a 0-10 scale)
- •Be able to perform the exercise intervention
- •Be able to read English
- •Be at least 18 years old (no upper limit on age)
- •Be consistently right-handed in daily activities for consistency in reporting any lateralized effects from brain imaging
- •Provide written informed consent
排除标准
- •Receive surgery, radiation, or hormone therapy for their cancer during the study
- •Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
- •Have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, etc. - note that most port-a-caths are safe for MRI scanning)
- •Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.
研究组 & 干预措施
Exercise
Exercise for Cancer Patients (EXCAP©®), developed by Dr. Karen Mustian, involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.
干预措施: EXCAP Exercise (Behavioral)
Nutrition Education Control
Nutrition education (control) involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.
干预措施: Nutrition Education Control (Behavioral)
结局指标
主要结局
Percent of patients screened who are eligible
时间窗: 12 weeks
Number of patients eligible divided by number of patients screened
Percent of patients eligible who are consented
时间窗: 12 weeks
Number of patients consented divided by number of patients approached
Percent of patients consented who complete the exercise intervention
时间窗: 12 weeks
Number of patients in exercise arm who improve daily steps divided by number of patients in exercise arm
Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy
时间窗: 12 weeks
Number of patients who completed pre- and post-intervention CIPN-20 questionnaire divided by number of patients consented (both arms)
次要结局
未报告次要终点
研究者
Ian Kleckner
Research Assistant Professor
University of Rochester