A Multicenter Investigator-Initiated Clinical Trial Evaluating the Effectiveness of Video-Based Movement Analysis-Guided Personalized Rehabilitation in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in mobility assessed by the Timed Up and Go (TUG) test
研究概览
简要总结
This study aims to quantify motor control abnormalities using video-based movement analysis in patients with chemotherapy-induced peripheral neuropathy (CIPN) and to evaluate the effectiveness of an analysis-guided personalized rehabilitation intervention. The study enrolls adult patients diagnosed with breast cancer, colorectal cancer, or gynecological cancer.
This is a randomized crossover trial where participants have an equal (50%) chance of being assigned to either Group A or Group B. The total participation period for each participant is approximately 8 weeks, which includes outcome assessments at baseline, week 4, and week 8.
The study consists of two periods:
Phase 1 (First 4 weeks): Group A participates in the 'ReMAP' rehabilitation exercise program, while Group B receives usual care.
Phase 2 (Next 4 weeks): Group A switches to usual care, while Group B participates in the 'ReMAP' rehabilitation exercise program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 19 years or older.
- •Diagnosed with breast cancer, colorectal cancer, or gynecological cancer, and currently receiving chemotherapy or under follow-up observation after completing treatment.
- •History of treatment with neurotoxic chemotherapeutic agents (e.g., taxane, platinum, etc.) or experiencing related symptoms.
- •Symptoms or risk of chemotherapy-induced peripheral neuropathy (CIPN) (NCI-CTCAE Grade >= 1).
- •Able to walk independently (with or without assistive devices).
- •Able to understand the study purpose and procedures and voluntarily provide written informed consent.
排除标准
- •Peripheral neuropathy clearly attributable to causes other than CIPN, such as diabetic neuropathy.
- •Severe central nervous system disorders (e.g., stroke, Parkinson's disease, etc.) or severe musculoskeletal disorders that make functional assessment or exercise performance difficult.
- •Severe cognitive impairment that interferes with study participation or the ability to follow instructions.
- •Recent significant injury due to a fall, or cases where exercise performance is deemed medically unsafe.
- •Recurrent or progressive cancer with an unstable general systemic condition.
- •Any other condition or clinical reason that, in the opinion of the investigator, makes participation in the study inappropriate.
研究组 & 干预措施
Active Comparator: Group A (ReMAP then Usual Care)
Participants randomized to Group A will first perform the 4-week 'ReMAP' rehabilitation program (Phase 1), and then cross over to receive 4 weeks of usual care (Phase 2).
干预措施: Usual Care (Behavioral)
Active Comparator: Group B (Usual Care then ReMAP)
Participants randomized to Group B will first receive 4 weeks of usual care (Phase 1), and then cross over to perform the 4-week 'ReMAP' rehabilitation program (Phase 2).
干预措施: ReMap (Behavioral)
Active Comparator: Group B (Usual Care then ReMAP)
Participants randomized to Group B will first receive 4 weeks of usual care (Phase 1), and then cross over to perform the 4-week 'ReMAP' rehabilitation program (Phase 2).
干预措施: Usual Care (Behavioral)
Active Comparator: Group A (ReMAP then Usual Care)
Participants randomized to Group A will first perform the 4-week 'ReMAP' rehabilitation program (Phase 1), and then cross over to receive 4 weeks of usual care (Phase 2).
干预措施: ReMap (Behavioral)
结局指标
主要结局
Change from baseline in mobility assessed by the Timed Up and Go (TUG) test
时间窗: Baseline, Week 4, and Week 8 (Primary comparison is the change from baseline to Week 4)
The TUG test measures the time (in seconds) it takes for a participant to rise from a chair, walk 3 meters, turn around, walk back, and sit down. Shorter completion times indicate better mobility and dynamic balance. This is the primary outcome of the study, which served as the basis for the sample size calculation.
次要结局
- Change from baseline in health-related quality of life assessed by the EORTC QLQ-C30(Baseline, Week 4, and Week 8)
- Change from baseline in chemotherapy-induced peripheral neuropathy (CIPN) symptoms assessed by the EORTC QLQ-CIPN20(Baseline, Week 4, and Week 8)
- Change from baseline in disability and functioning assessed by the WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0)(Baseline, Week 4, and Week 8)
- Change from baseline in fall risk assessed by the Fall Assessment Scale - Korean version (FAS-K)(Baseline, Week 4, and Week 8)
- Change from baseline in walking endurance assessed by the 6-Minute Walk Test (6MWT)(Baseline, Week 4, and Week 8)
- Change from baseline in handgrip strength(Baseline, Week 4, and Week 8)
- Change from baseline in kinematic parameters of movement assessed by video-based motion analysis(Baseline, Week 4, and Week 8)
研究者
Eun Joo Yang
Clinical Associate Professor
Seoul National University Bundang Hospital