The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessor and investigator will be masked of Arms to the extent possible (i.e., for some outcomes e.g., biomarkers but not others e.g. symptom tests).
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
- •(subjects must…)
- •Have breast cancer
- •Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)
- •Have at least six months life expectancy according to the patient's oncologist or designee
- •Be able to read English
- •Be at least 18 years old (no upper limit on age)
- •Provide written informed consent
排除标准
- •(subjects must not…)
- •Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
- •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.
- •Additional exclusion criteria only for patients performing the MRI scanning (40 of 80 enrolled subjects)
- •1. Subjects must not have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, chest expander from breast reconstruction, etc.-note that most port-a-caths are safe for MRI scanning)
研究组 & 干预措施
Exercise
Exercise for Cancer Patients (EXCAP©®) 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
Nutrition education 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 (Behavioral)
结局指标
主要结局
Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)
时间窗: Time point 2 (approximately 6 weeks), controlling for baseline value
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
次要结局
- Sensory loss(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline)
- Sensory, motor, and autonomic symptoms of CIPN(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline)
- Patient-reported sensory symptoms of CIPN(Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline)
- Numbness and tingling(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline)
研究者
Po-Ju Lin
Assistant Professor
University of Rochester