Peripheral Neuropathy, Secondary to Drugs or ChemicalsEX-CIPNNCT07399561
Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy
A study testing Exercise Intervention in people with Peripheral Neuropathy, Secondary to Drugs or Chemicals and Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Peripheral Neuropathy, Secondary to Drugs or Chemicals, Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Paclitaxel Induced Neuropathy
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
National Cancer Center
Goyang, Gyeonngi, 10408
Su-Hyun Kim,, MD, PhD, 82-31-920-1683, herena20@ncc.re.kr
About this study
Official title: A Randomized Controlled Trial Evaluating the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy in Patients Treated With Oxaliplatin or Paclitaxel
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.
Read the 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
- Being tested
- Exercise Intervention, Usual Care
- Keywords
- chemotherapy induced peripheral neuropathy, CIPN, Exercise
- Medical subject headings
- Peripheral Nervous System Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
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 CareOther
Standard oncologic care and general education regarding chemotherapy-induced peripheral neuropathy, without a structured exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | 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. Receives: Behavioral: Exercise Intervention |
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (14)
Blood Biomarkers
Serum neurofilament light chain (NfL), brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), complement components (e.g., C5a), and inflammatory cytokines.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start3 Feb 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy, Secondary to Drugs or ChemicalsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Su-hyun Kim, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399561
- Sponsor's protocol ID
- NCC-CIPN-EX-2025
- Acronym
- EX-CIPN
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy in Patients Treated With Oxaliplatin or Paclitaxel
- ClinicalTrials.gov ID
- NCT07399561
- Acronym / sponsor ID
- EX-CIPN / NCC-CIPN-EX-2025
- Conditions
- Peripheral Neuropathy, Secondary to Drugs or Chemicals, Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Paclitaxel Induced Neuropathy
- Keywords
- chemotherapy induced peripheral neuropathy, CIPN, Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 3 Feb 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionParticipants 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. |
| Usual Care | Active comparator | Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionA 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. | Behavioural | Exercise Intervention |
| Usual CareStandard oncologic care and general education regarding chemotherapy-induced peripheral neuropathy, without a structured exercise program. | Other | Usual Care |
Primary outcome
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).
14 secondary outcomes
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.
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 Circulating Inflammatory Cytokine Levels
Time frame: Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the manuscript.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Peripheral Neuropathy, Secondary to Drugs or Chemicals and Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Su-Hyun Kim, MD, PhD (82-31-920-1683, herena20@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.