NCT07399561

Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy

A Randomized Controlled Trial Evaluating the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy in Patients Treated With Oxaliplatin or Paclitaxel

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral Neuropathy, Secondary to Drugs or Chemicals
• Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients
• Paclitaxel Induced Neuropathy

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Intervention	A structured home-based exercise program performed during chemotherapy and for up to three months after completion of chemotherapy. The program includes aerobic and strengthening exercises and is designed to be safe and feasible during active cancer treatment. Adherence is monitored through regular telephone follow-up.
OTHER	Usual Care	Standard oncologic care and general education regarding chemotherapy-induced peripheral neuropathy, without a structured exercise program.

Timeline

• Start date: 2026-02-03
• Primary completion: 2027-07-01
• Completion: 2027-12-31
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: South Korea