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
- 4
- 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
- 未提供
排除标准
- 未提供
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