A Remotely Delivered Exercise-Based Rehabilitation Program for Patients with Persistent Chemotherapy-Induced Peripheral Neuropathy (EX-CIPN): A Phase I Feasibility Trial

Abstract

Background: Chemotherapy-induced peripheral neuropathy (CIPN) affects two-thirds of patients who receive neurotoxic chemotherapy. In almost half of these patients, CIPN is persistent, with limited treatment options. Exercise-based rehabilitation shows promising results in improving CIPN-related outcomes, but high-quality research is needed with CIPN symptoms and disability as primary endpoints. Methods: We conducted a phase I single-arm, multi-method pilot study of a 10-week remotely delivered exercise-based rehabilitation program (EX-CIPN) for adult (≥18-years) cancer survivors experiencing CIPN symptoms ≥6 months post-chemotherapy. Primary outcomes were feasibility (accrual, retention, and adherence), acceptability (interviews and surveys), and safety (CTCAE v5). Secondary outcomes included pain, CIPN symptoms, CIPN-related disability, and physiologic assessments. Assessments were conducted at baseline (T1), post-program (T2), and 3 months post-program (T3). Post-program feedback surveys were completed at T2 and semi-structured qualitative video interviews were completed between T2 and T3. Results: In total, 36 participants (median age: 59, 83% female) consented to participate in the study. T1 retention rate (90%), adherence rates (77–96%), and no reported serious adverse events (Grade 3 CTCAE v5) supported study feasibility and safety. Interviews and surveys supported intervention acceptability. Retention rates at T2 (68%) and T3 (63%) did not reach feasibility targets. CIPN symptoms and CIPN-related disability showed significant improvement at T3 (p < 0.001). Conclusions: Results suggest that EX-CIPN has encouraging feasibility outcomes and is acceptable and safe. Preliminary clinical outcome results are promising. Based on these study results, we can proceed to test this intervention, with a few modifications, in a prospective randomised trial with a CIPN-related primary outcome.