Antonen Eric M, Nadler Michelle B, Langelier David M, Campbell Kristin L, Flamer David, Cho Jang Hyuk, Capozza Scott, Avery Lisa, Bland Kelcey A, Leatherdale Scott, Manthorne Jackie, Jones Jennifer M
Department of Supportive Care, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Institute of Medical Sciences, University of Toronto, Toronto, Ontario, Canada.
PLoS One. 2025 Apr 29;20(4):e0322371. doi: 10.1371/journal.pone.0322371. eCollection 2025.
Chemotherapy-induced peripheral neurotoxicity (CIPN) is a prevalent adverse effect of chemotherapy agents that is estimated to be present in 2/3 of patients who receive neurotoxic chemotherapy. In 30-40% of these patients, CIPN signs and symptoms can persist for months or years post-treatment. Recent studies have supported exercise as a feasible and possibly effective intervention for CIPN; however, more rigorous studies are needed to confirm feasibility, estimate efficacy, and clarify risk. In response, we developed an innovative virtual exercise-based rehabilitation program (EX-CIPN) for cancer survivors with persistent CIPN.
This study is a phase I study conducted at the Princess Margaret Cancer Centre in cancer survivors with persistent CIPN, with a focus on feasibility, acceptability, and safety. A total of 40 patients aged 18 or older, with persistent CIPN at least 6 months after chemotherapy completion will be recruited and receive the EX-CIPN program. The EX-CIPN program is a 10-week virtual home-based intervention that includes an individualized exercise program supported with a mobile application (Physitrack), wearable technology (FitBit), and weekly virtual check-ins with an oncology exercise specialist. The primary outcome of feasibility will be assessed by examining accrual, retention, and adherence rates. Acceptability will be assessed through qualitative interviews. Safety events will be monitored and reported based on CTCAE v5. Secondary outcomes will be collected using questionnaires and physiological assessments at baseline (T1), after the intervention (T2), and 3-months after intervention (T3).
This phase I study will determine intervention feasibility, acceptability, and safety and will inform the planning for a future Phase II RCT with the EX-CIPN intervention.
化疗引起的周围神经毒性（CIPN）是化疗药物常见的不良反应，据估计，接受有神经毒性化疗的患者中有三分之二会出现这种情况。在这些患者中，30%-40%的人CIPN的体征和症状在治疗后可持续数月或数年。最近的研究支持运动作为一种可行且可能有效的CIPN干预措施；然而，需要更严格的研究来确认其可行性、评估疗效并明确风险。为此，我们为患有持续性CIPN的癌症幸存者开发了一种创新的基于虚拟运动的康复计划（EX-CIPN）。
本研究是在玛格丽特公主癌症中心对患有持续性CIPN的癌症幸存者进行的I期研究，重点是可行性、可接受性和安全性。总共将招募40名18岁及以上、化疗结束后至少6个月患有持续性CIPN的患者，并让他们接受EX-CIPN计划。EX-CIPN计划是一项为期10周的基于家庭的虚拟干预措施，包括一个个性化的运动计划，该计划由移动应用程序（Physitrack）、可穿戴技术（FitBit）提供支持，并每周与肿瘤运动专家进行虚拟签到。可行性的主要结果将通过检查入组率、保留率和依从率来评估。可接受性将通过定性访谈进行评估。将根据CTCAE v5监测和报告安全事件。次要结果将在基线（T1）、干预后（T2）和干预后3个月（T3）使用问卷和生理评估进行收集。
这项I期研究将确定干预措施的可行性、可接受性和安全性，并为未来使用EX-CIPN干预措施进行II期随机对照试验的规划提供信息。
