Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise Intervention, Usual Care.
- Who it may be relevant to
- Registry conditions: Peripheral Neuropathy, Secondary to Drugs or Chemicals, Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Paclitaxel Induced Neuropathy. Basic parameters: 19 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial Evaluating the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy in Patients Treated With Oxaliplatin or Paclitaxel
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in Chemotherapy-Induced Peripheral Neuropathy Severity (CTCAE v5.0) [Time frame: Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.]
Secondary outcome measures (12)
- Blood Biomarkers [Time frame: Baseline, end of chemotherapy, 3 months post-chemotherapy]
- Quality of Life Assessed by EORTC QLQ-C30 [Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
- Change in Timed Up and Go Test Performance [Time frame: 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 [Time frame: 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 [Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
- Change in Serum Neurofilament Light Chain Concentration [Time frame: 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 [Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
- Change in Serum Complement Component C5a Level [Time frame: 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 [Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
- Change in 2-Minute Walk Test Distance [Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
- Change in Handgrip Strength [Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.]
- Secondary Outcome: Sensory Nerve Conduction Velocity [Time frame: Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.]
Eligibility criteria
Inclusion criteria
- Diagnosis of colorectal cancer (oxaliplatin cohort) or gynecologic cancer (paclitaxel cohort)
- Planned initiation of oxaliplatin- or paclitaxel-based chemotherapy
- Karnofsky Performance Status ≥70
- Ability to provide written informed consent
Exclusion criteria
- Pre-existing peripheral neuropathy from other causes
- Severe comorbidities limiting safe participation in exercise
- Regular participation in a structured moderate- to high-intensity exercise program comparable to the study intervention prior to enrollment.
- Cognitive impairment interfering with study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- National Cancer Center — Goyang
Identifiers
NCT: NCT07399561 · NCC-CIPN-EX-2025