Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy

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.

• Blood Biomarkers [Срок оценки: Baseline, end of chemotherapy, 3 months post-chemotherapy]
• Quality of Life Assessed by EORTC QLQ-C30 [Срок оценки: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
• Change in Timed Up and Go Test Performance [Срок оценки: Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.]
• Change in Sensory Nerve Action Potential Amplitude [Срок оценки: Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.]
• Change in Patient-Reported CIPN Symptoms Assessed by EORTC QLQ-CIPN20 [Срок оценки: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
• Change in Serum Neurofilament Light Chain Concentration [Срок оценки: Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.]
• Change in Serum Brain-Derived Neurotrophic Factor Level [Срок оценки: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
• Change in Serum Complement Component C5a Level [Срок оценки: Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.]
• Change in Sit-to-Stand Test Performance [Срок оценки: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
• Change in 2-Minute Walk Test Distance [Срок оценки: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
• Change in Handgrip Strength [Срок оценки: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
• Secondary Outcome: Sensory Nerve Conduction Velocity [Срок оценки: Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.]