Exercise to Reduce Chemotherapy-Induced Peripheral Neuropathy: A Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 14
- 主要终点
- Sensory neuropathy at 8 weeks
研究概览
简要总结
This randomized, controlled, pilot experiment will evaluate the effects of an aerobic walking intervention on OIPN (oxaliplatin-induced peripheral neuropathy) in patients with gastrointestinal (GI) cancer who are already prescribed oxaliplatin (85 mg/m2 every other week for at least six cycles) by their oncologists. Oxaliplatin is a standard chemotherapy treatment for invasive GI cancers that causes OIPN in 85-95% of patients.
详细描述
Background: Over 190,000 men and women will be diagnosed in 2018 with invasive gastrointestinal (GI) cancers (e.g, colorectal and gastric cancer) for which oxaliplatin is a standard chemotherapy treatment. However, 85-95% of these patients develop oxaliplatin-induced peripheral neuropathy (OIPN). Currently, OIPN is the primary dose-limiting factor of oxaliplatin-based regimens, because persistent OIPN can impair physical function and quality of life (QOL) years after treatment completion. There are no effective treatments for OIPN. Four randomized controlled trials and two quasi-experiments have reported positive effects of at least 10 minutes/day of moderate-intensity aerobic exercise, 2-5 days/week over at least 6-8 weeks on chemotherapy-induced peripheral neuropathy. Exercise-enhanced circulation could re-distribute neurotoxic drugs away from vulnerable neurons, reduce oxidative stress, and help to prevent OIPN. However, all the prior trials had critical study limitations and all but two studies evaluated OIPN as a secondary outcome. Thus, this prospective, randomized, controlled, pilot experiment will evaluate the efficacy of an aerobic walking intervention for OIPN in GI cancer patients who are already prescribed oxaliplatin (85 mg/m2 every other week for at least six cycles) by their oncologists. The "MI-Walk intervention"- an 8-week motivational enhancement therapy (MET)- and home-based aerobic walking intervention-will be tested in this study.
Specific aims: The specific aims and hypotheses are to:
Aim 1: Evaluate the effect of the MI-Walk Intervention on OIPN severity at 8 weeks (T6) compared to physical activity (PA) education alone.
Hypothesis: Participants who receive the MI-Walk intervention will exhibit less severe OIPN at T6 than participants who receive PA education alone.
Aim 2: Explore the effect of the MI-Walk intervention on total oxaliplatin received, and QOL at T6 compared to PA education alone.
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
- 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
- •Diagnosed GI cancer (e.g, colorectal, gastric, pancreatic, esophageal, bowel);
- •Scheduled to receive at least 6 cycles of oxaliplatin (85 mg/m2);
- •Receiving care at the University of Michigan or St. Joseph Cancer Clinics;
- •A Karnofsky Performance Status ≥ 80% or an Eastern Cooperative Oncology Group Status 0 to 1;
- •Voluntarily consented to participate in all intervention components.
排除标准
- •Exercise- or mobility-limiting cardiovascular, pulmonary, musculoskeletal, or psychological disease, based on the EMR (electronic medical record) past medical history and consultation with the medical oncologist;
- •Scheduled major surgery during the study time period;
- •Pre-existing peripheral neuropathy prior to chemotherapy (potentially due to diabetes, central nervous system malignancy, vitamin deficiency, heredity, nerve compression injury, non-surgically corrected carpal tunnel disease, or alcohol dependence) per patient self-report in response to brief screening questions noted in the pre-screening section;
- •Pregnancy;
- •Inability to read or speak English;
- •Prognosis of less than three months.
结局指标
主要结局
Sensory neuropathy at 8 weeks
时间窗: At 8 weeks
The 9-item European Organisation of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy Scale (CIPN20) sensory subscale will be used to measure sensory neuropathy. Each item is rated on a scale from 1 ("not at all") to 4 ("very much"), and the total raw score ranges from 9 to 36. The raw scores will be linearly transformed to a 0 to 100 scale (higher scores represent worse CIPN severity).
次要结局
- Oxaliplatin dose at 8 weeks(At 8 weeks)
- Motor Neuropathy at 8 weeks(At 8 weeks)
- Autonomic Neuropathy at 8 weeks(At 8 weeks)
- Quality of life at 8 weeks(At 8 weeks)
- Mood at 8 weeks(At 8 weeks)