EX-CIPN: An Exercise-based Rehabilitation Intervention to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Retention Rates
研究概览
简要总结
The goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (CIPN). It will also give insight on the effectiveness of the exercise intervention in treating CIPN symptoms. The main questions it aims to answer are:
- Is EX-CIPN safe, acceptable, and feasible in cancer survivors experiencing persistent CIPN?
- Are the study design and methods feasible (recruitment and retention rates, feasibility of data collection and procedures)?
Researchers will provide all participants with the exercise-based intervention.
Participants will:
- Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention
- Complete a 10-week remote, individualized exercise program
- Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention
- Wear a FitBit throughout the study to track physical activity and promote behaviour change
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Received a diagnosis of any cancer and treated with curative intent (no minimum dose) including Stage 3 & 4 gynecologic malignancies, treated in the platinum-sensitive setting
- •Are > 6 months post-completion of chemotherapy (ie no other chemotherapeutic agents since completing of the chemotherapy regimen)
- •Report > Grade 1 on the Patient Reported NCI Common Terminology Criteria for Adverse Events version 5.0 grading scale (numbness and tingling severity item) and neuropathic pain >3 on the Neuropathic Pain 4 (DN4) (interview) (0-7)
- •The presence of peripheral neuropathy due to chemotherapy (following onset of chemotherapy), as established via clinical assessment
- •May be on maintenance oncologic therapies (ie endocrine therapy, Poly (ADP-ribose) polymerase (PARP) inhibitors) not known to cause neuropathy
- •No current plans for chemotherapy in the next 6 months
- •Currently engaging in < 90min per week of planned moderate-intensity aerobic exercise
- •Independent with ambulation and transfers with or without ambulatory assistance (EGOG 0-2)
- •Able to communicate sufficiently in English to complete intervention, questionnaires, and consent
- •Willing to participate in the intervention and attend in-person physical assessments
- •Have access to and are able to operate videoconferencing.
排除标准
- •Known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations
- •Pre-existing neuropathy prior to the start of chemotherapy
- •Are currently enrolled in other cancer rehabilitation or exercise-based programs/interventions.
- •Are currently taking ado-trastuzumab emtansine (TDM1) (ex. Kadcyla)
研究组 & 干预措施
EX-CIPN Exercise- Based intervention
This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support.
干预措施: EX-CIPN (Behavioral)
结局指标
主要结局
Retention Rates
时间窗: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Retention rates will be calculated as the proportion of participants that attend each assessment time point. The investigators will also examine rates of complete and missing data.
Accrual Rate
时间窗: Throughout study completion, up to 24 weeks.
Assessed based on CONSORT criteria through a screening log that tracks data collected of all screened patients. Eligibility screening will be performed to identify eligible consented and eligible non-recruited individuals with non-recruitment reasons documented. Number of participants consented and enrolled will be tracked each month.
Adherence
时间窗: Through study completion, up to 24 weeks.
Assessed through health coaching call attendance, Fitbit™ usage, and self-report completion of weekly exercise plan
Intervention Safety
时间窗: Through study completion, up to 24 weeks.
All adverse events will be scored on the CTCAE version 5.0 and documented during weekly appointments and at follow-up assessments with the Registered Kinesiologist (RKin). Assessment, tests, and all exercises will be stopped at any time if any pain or discomfort is experienced.
次要结局
- CIPN Symptoms(Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks))
- Strength (Upper Body)(Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks))
- Gait Speed(Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks))
- Strength (Lower Body)(Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks))
- Aerobic Functional Capacity(Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks))
- Pain Intensity(Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks))
- CIPN-related Disability(Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks))
- Balance(Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks))