A Randomized Controlled Trial Evaluating the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy in Patients Treated With Oxaliplatin or Paclitaxel
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in Chemotherapy-Induced Peripheral Neuropathy Severity (CTCAE v5.0)
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often persistent adverse effect of oxaliplatin- and paclitaxel-based chemotherapy. While exercise is frequently recommended for patients with CIPN, it remains unclear whether exercise mitigates neuropathic injury itself or primarily improves physical function and quality of life.
This randomized controlled trial evaluates the effects of exercise on CIPN during and after chemotherapy. Patients receiving oxaliplatin for colorectal cancer or paclitaxel for gynecologic cancer are randomized to an exercise intervention or usual-care control. Neuropathy severity is assessed using objective neurophysiological measures, blood biomarkers, and validated clinical and patient-reported outcomes.
详细描述
This is an open-label, randomized controlled trial conducted in patients undergoing neurotoxic chemotherapy. Two chemotherapy cohorts are included: patients receiving oxaliplatin-based chemotherapy for colorectal cancer and patients receiving paclitaxel-based chemotherapy for gynecologic cancer.
Participants are randomized 1:1 to an exercise intervention group or a usual-care control group. Randomization is performed prior to chemotherapy initiation, with stratification by age group and chemotherapy regimen to ensure balance between groups.
The exercise intervention consists of a structured home-based exercise program initiated at the start of chemotherapy and continued until three months after completion of chemotherapy. The program is designed to be safe and feasible during active cancer treatment, with adherence monitored through regular follow-up.
The primary objective is to determine whether exercise reduces the severity of chemotherapy-induced peripheral neuropathy, as assessed by objective neurophysiological testing and validated patient-reported measures. Secondary objectives include evaluation of blood biomarkers of neuroaxonal injury and inflammation, physical function, and quality of life.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of colorectal cancer (oxaliplatin cohort) or gynecologic cancer (paclitaxel cohort)
- •Planned initiation of oxaliplatin- or paclitaxel-based chemotherapy
- •Karnofsky Performance Status ≥70
- •Ability to provide written informed consent
排除标准
- •Pre-existing peripheral neuropathy from other causes
- •Severe comorbidities limiting safe participation in exercise
- •Regular participation in a structured moderate- to high-intensity exercise program comparable to the study intervention prior to enrollment.
- •Cognitive impairment interfering with study participation
研究组 & 干预措施
Exercise Intervention
Participants assigned to this arm will perform a structured home-based exercise program during chemotherapy and for up to three months after completion of chemotherapy. The exercise program is designed to be safe and feasible during active cancer treatment and includes aerobic and strengthening components. Participants receive standardized exercise education materials, and adherence and safety are monitored through regular telephone follow-up.
干预措施: Exercise Intervention (Behavioral)
Usual Care
Participants assigned to this arm will receive standard oncologic care and general education regarding chemotherapy-induced peripheral neuropathy. No structured exercise program is prescribed during the study period.
干预措施: Usual Care (Other)
结局指标
主要结局
Change in Chemotherapy-Induced Peripheral Neuropathy Severity (CTCAE v5.0)
时间窗: Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.
Change in chemotherapy-induced peripheral neuropathy severity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 sensory neuropathy grade (Grade 0-4, with higher grades indicating more severe neuropathy).
次要结局
- Blood Biomarkers(Baseline, end of chemotherapy, 3 months post-chemotherapy)
- Quality of Life Assessed by EORTC QLQ-C30(Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.)
- Change in Timed Up and Go Test Performance(Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.)
- Change in Sensory Nerve Action Potential Amplitude(Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.)
- Change in Patient-Reported CIPN Symptoms Assessed by EORTC QLQ-CIPN20(Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.)
- Change in Serum Neurofilament Light Chain Concentration(Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.)
- Change in Serum Brain-Derived Neurotrophic Factor Level(Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.)
- Change in Serum Complement Component C5a Level(Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.)
- Change in Sit-to-Stand Test Performance(Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.)
- Change in 2-Minute Walk Test Distance(Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.)
- Change in Handgrip Strength(Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.)
- Secondary Outcome: Sensory Nerve Conduction Velocity(Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.)
- Change in Serum Nerve Growth Factor Level(Baseline, end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.)
- Change in Circulating Inflammatory Cytokine Levels(Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.)
研究者
Su-hyun Kim
Head of Department of Neurology
National Cancer Center, Korea