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NCT Number: NCT07399561

Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy

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.

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Key information

Conditions

Peripheral Neuropathy, Secondary to Drugs or Chemicals Behavior Motor Activity Nervous System Diseases Neuromuscular Diseases Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients Paclitaxel Induced Neuropathy Peripheral Nervous System Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

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.

Usual Care

Other

Standard oncologic care and general education regarding chemotherapy-induced peripheral neuropathy, without a structured exercise program.

Primary outcomes

  1. 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.

    Change in chemotherapy-induced peripheral neuropathy severity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 sensory neuropathy grade (Grade 0-4, with higher grades indicating more severe neuropathy).

Secondary outcomes

  1. Blood Biomarkers

    Time frame: Baseline, end of chemotherapy, 3 months post-chemotherapy

    Serum neurofilament light chain (NfL), brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), complement components (e.g., C5a), and inflammatory cytokines.

  2. 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.

    Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The questionnaire generates scores ranging from 0 to 100. For the global health status and functional scales, higher scores indicate better quality of life and functioning, whereas for symptom scales, higher scores indicate greater symptom burden.

  3. 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 mobility and balance assessed using the Timed Up and Go (TUG) test, measured in seconds, with longer times indicating poorer performance.

  4. 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 sensory nerve action potential (SNAP) amplitude of predefined sensory nerves assessed by nerve conduction studies, measured in microvolts (µV), with lower amplitudes indicating greater axonal dysfunction.

  5. 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 chemotherapy-induced peripheral neuropathy symptoms assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item scale (EORTC QLQ-CIPN20; score range 0-100, with higher scores indicating worse neuropathy).

  6. 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 neurofilament light chain (NfL) concentration, a biomarker of neuroaxonal injury, measured using a validated immunoassay.

  7. 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 brain-derived neurotrophic factor (BDNF) level, measured using a single molecule array (SIMOA) immunoassay.

  8. 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 serum complement component C5a level, a marker of complement activation, measured using the MicroVue™ C5a enzyme immunoassay.

  9. 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 lower extremity functional strength assessed using the Sit-to-Stand test, measured as time to complete the test or number of repetitions, as applicable.

  10. 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 functional exercise capacity assessed using the 2-Minute Walk Test, measured as total distance walked in meters.

  11. Change in Handgrip Strength

    Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.

    Change in upper extremity muscle strength assessed using handgrip dynamometry, measured in kilograms, with lower values indicating reduced strength.

  12. 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.

    Change in sensory nerve conduction velocity of predefined sensory nerves assessed by nerve conduction studies, measured in meters per second (m/s), with lower velocities indicating greater demyelination or conduction slowing.

  13. Change in Serum Nerve Growth Factor Level

    Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.

    Change in serum nerve growth factor (NGF) level, measured using a validated immunoassay.

  14. Change in Circulating Inflammatory Cytokine Levels

    Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.

    Change in circulating levels of selected pro- and anti-inflammatory cytokines measured using a multiplex enzyme-linked immunosorbent assay.

Study contacts

Contact information is provided by the study sponsor or research team.

Su-Hyun Kim, MD, PhD

CONTACT

[email protected]

82-31-920-1683

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Acronym: EX-CIPN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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