An interventional study of Exercise Intervention and Usual Care in Peripheral Neuropathy, Secondary to Drugs or Chemicals, Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients and Paclitaxel Induced Neuropathy, sponsored by National Cancer Center, Korea. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by National Cancer Center, Korea · Not applicable, Interventional, and Prevention
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.
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.
476 studies on the registry are indexed under Peripheral Nervous System Diseases; 103 are open to participants now.
This study's planned enrollment of 140 is above the median of 57 across 359 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →National Cancer Center, Korea is the lead sponsor of 204 studies on the registry; 36 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will perform a structured home-based exercise program during chemotherapy and for up to three months after completion of chemotherapy. The exercise program is designed to be safe and feasible during active cancer treatment and includes aerobic and strengthening components. Participants receive standardized exercise education materials, and adherence and safety are monitored through regular telephone follow-up.
Behavioral: Exercise Intervention
Participants assigned to this arm will receive standard oncologic care and general education regarding chemotherapy-induced peripheral neuropathy. No structured exercise program is prescribed during the study period.
Other: Usual Care
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.
Standard oncologic care and general education regarding chemotherapy-induced peripheral neuropathy, without a structured exercise program.
Change in Chemotherapy-Induced Peripheral Neuropathy Severity (CTCAE v5.0)
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).
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.
Blood Biomarkers
Serum neurofilament light chain (NfL), brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), complement components (e.g., C5a), and inflammatory cytokines.
Time frame: Baseline, end of chemotherapy, 3 months post-chemotherapy
Quality of Life Assessed by EORTC QLQ-C30
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.
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
Change in mobility and balance assessed using the Timed Up and Go (TUG) test, measured in seconds, with longer times indicating poorer 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
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.
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
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).
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
Change in serum neurofilament light chain (NfL) concentration, a biomarker of neuroaxonal injury, measured using a validated immunoassay.
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
Change in serum brain-derived neurotrophic factor (BDNF) level, measured using a single molecule array (SIMOA) immunoassay.
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
Change in serum complement component C5a level, a marker of complement activation, measured using the MicroVue™ C5a enzyme immunoassay.
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
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.
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
Change in functional exercise capacity assessed using the 2-Minute Walk Test, measured as total distance walked in meters.
Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.
Change in Handgrip Strength
Change in upper extremity muscle strength assessed using handgrip dynamometry, measured in kilograms, with lower values indicating reduced 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
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.
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 Nerve Growth Factor Level
Change in serum nerve growth factor (NGF) level, measured using a validated immunoassay.
Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.
Change in Circulating Inflammatory Cytokine Levels
Change in circulating levels of selected pro- and anti-inflammatory cytokines measured using a multiplex enzyme-linked immunosorbent assay.
Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.
Plan to share: Yes — De-identified individual participant data underlying the results reported in the manuscript.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.
Access criteria: Individual participant data will be shared upon reasonable request. Requests must include a methodologically sound proposal and be approved by the study investigators. Data will be shared after execution of a data sharing agreement, in accordance with institutional policies and applicable regulations.
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Jul 2027, 16 months later.
Of 122 non-industry interventional studies with no phase under Peripheral Nervous System Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 16 months is below that.
Counting every sponsor, half of 132 studies reached it within 25 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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