Chemotherapy Induced Peripheral Neuropathy (CIPN)CIPN-NEXTNCT07913958
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
A study testing Exercise program 1: aerobic + resistance training and Exercise program 2: aerobic + resistance training combined with neurodynamic exercises in people with Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Universiteit Antwerpen at 2 sites in Belgium.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and potentially persistent side effect of neurotoxic chemotherapy, characterized by symptoms such as numbness, tingling, pain, and sensory dysfunction in the hands and feet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Exercise program 1: aerobic + resistance training and Exercise program 2: aerobic + resistance training combined with neurodynamic exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesBelgium
- Study dates
- 10 Nov 2026to 1 Nov 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years
- Primary diagnosis of breast, colon or gynaecological cancer
- Undergoing taxane- or oxaliplatin-based chemotherapy, or having completed this treatment within the previous 3 months
- At least one self-reported symptom consistent with chemotherapy-induced peripheral neuropathy, including numbness, tingling and/or pain in a stocking (feet) and/or glove (hand) distribution, as assessed by the EORTC QLQ-CIPN20 sensory subscale, which emerged during the current course of neurotoxic chemotherapy or within 3 months following its completion
Who cannot join
- Pre-existing peripheral neuropathy or neurological conditions that could account for the reported symptoms, including persistent CIPN from a previous chemotherapy regimen, radiculopathy, entrapment neuropathies, or other non-chemotherapy-related neuropathies
- An Eastern Cooperative Oncology Group (ECOG) performance status above one
- Life expectancy of less than six months according to the patient's oncologist or designee
- Any medical condition that contraindicates safe participation in a low- to moderate-intensity aerobic and resistance exercise program
- Meeting current physical activity guidelines (>150 min/week of moderate-to-vigorous physical activity) or participation in a structured exercise program comparable to the study intervention
- Not able to provide informed consent
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mira Meeus, Prof. contact
Belgium2 sites
Antwerp University Hospital
Edegem, 2650
Lore Dams, Dr., +32 3 265 16 59, lore.dams@uzleuven.be
University Hospital Leuven
Leuven, 3000
Lore Dams, Dr., +32 3 265 16 59, lore.dams@uzleuven.be
About this study
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and potentially persistent side effect of neurotoxic chemotherapy, characterized by symptoms such as numbness, tingling, pain, and sensory dysfunction in the hands and feet. These symptoms may negatively affect physical functioning, quality of life, and participation in daily activities.
Exercise therapy has emerged as a promising non-pharmacological intervention for individuals with CIPN. However, it remains unclear which exercise approach is most effective. Neurodynamic interventions have shown beneficial effects in other peripheral neuropathic conditions but have not yet been adequately investigated in individuals with CIPN.
Read more
The objective of the CIPN-NEXT trial is to evaluate the effectiveness of two exercise-based rehabilitation programmes in individuals with CIPN. Participants will be randomized to one of three study arms: (1) aerobic and resistance exercise, (2) aerobic and resistance exercise combined with neurodynamic interventions, or (3) a wait-list control group.
The study aims to determine whether the addition of neurodynamic interventions provides additional benefit beyond exercise therapy alone with regard to CIPN symptoms, physical functioning, psychosocial functioning, and quality of life. Furthermore, the study will explore potential underlying mechanisms associated with symptom development and recovery.
- Being tested
- Exercise program 1: aerobic + resistance training, Exercise program 2: aerobic + resistance training combined with neurodynamic exercises
- Keywords
- chemotherapy induced peripheral neuropathy, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise program 1: aerobic + resistance trainingBehavioural
- 30-minute face-to-face session with physiotherapist outlining the state of the science on the importance and benefits of physical activity during and after cancer treatment and advising patients to engage in regular physical activity according to the general guidelines
- Activity tracker
- 12-week individually tailored exercise program
- Supervised and home-based aerobic exercise, 5 times per week at moderate intensity
- Supervised resistance exercises, 2 times per week
Exercise program 2: aerobic + resistance training combined with neurodynamic exercisesBehavioural
- 30-minute face-to-face session with physiotherapist outlining the state of the science on the importance and benefits of physical activity during and after cancer treatment and advising patients to engage in regular physical activity according to the general guidelines
- Activity tracker
- 12-week individually tailored exercise program
- Supervised and home-based aerobic exercise, 5 times per week at moderate intensity
- Supervised resistance exercises, 2 times per week
- Supervised and home-based neurodynamic exercises, 5 times per week
| Study group | Role | What they receive |
|---|---|---|
| Exercise program 1: aerobic + resistance training | Active comparator | Participants receive advice on physical activity and an activity tracker to monitor physical activity levels, in addition they receive a 12-week individually tailored exercise program consisting of aerobic and resistance training. Receives: Behavioral: Exercise program 1: aerobic + resistance training |
| Exercise program 2: aerobic + resistance training combined with neurodynamic exercises | Experimental | Participants receive advice on physical activity and an activity tracker to monitor physical activity levels, in addition they receive a 12-week individually tailored exercise program consisting of aerobic training, resistance training and neurodynamic exercises. Neurodynamic exercises are integrated within the exercise program and are progressively adapted according to symptom response. Receives: Behavioral: Exercise program 2: aerobic + resistance training combined with neurodynamic exercises |
| Wait-list control | No intervention | Participants receive advice on physical activity and an activity tracker to monitor physical activity levels. After 12 weeks, participants are offered the opportunity to participate in Exercise Program 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity
To evaluate the primary outcome sensory symptoms of CIPN, the Quality of Life Questionnaire-CIPN twenty-item scale will be used (QLQ-CIPN20 sensory subscale, score range from 9 to 36, higher scores indicating more sensory symptoms or problems).
Measured: at 12 weeks follow-up
Secondary outcomes (15)
Chemotherapy-induced peripheral neuropathy (CIPN) sensory, motor and autonomic symptom severity
To evaluate the sensory, motor and autonomic symptoms of CIPN, the Quality of Life Questionnaire-CIPN twenty-item scale will be used (QLQ-CIPN20). Each subscale score will be linearly transformed to a 0-100 scale with higher scores indicating greater symptom burden.
Measured: at baseline, 4, 8, 12 and 24 weeks follow-up
Chemotherapy-induced peripheral neuropathy (CIPN) signs
The Total Neuropathy Score clinical version (TNSc) is used to evaluate motor symptoms, pin sensation, vibration sensibility, tendon reflexes and strength in the hands and feet (score range 0-20, higher scores indicating greater severity of neuropathy).In addition, quantitative sensory testing (QST) is performed to assess sensory nerve function, including vibration, thermal and mechanical detection and pain thresholds. Together, these measures provide a comprehensive assessment of clinical signs and sensory dysfunction associated with CIPN.
Measured: at baseline, 12 and 24 weeks follow-up
Pain severity hands and feet
Pain severity in the hands and feet will be evaluated with a Visual Analogue Scale (VAS). Four VAS scales will be completed: pain intensity at the present moment, mean pain intensity (global average pain intensity over the past week), maximum pain intensity (pain intensity at its maximum over the past week) and minimum pain intensity (pain intensity at its minimum over the past week).
Measured: at baseline, 4, 8, 12 and 24 weeks follow-up
General pain location and interference
Pain location and pain interference will be evaluated with the Brief Pain Inventory (BPI), including a body diagram to identify painful body areas and a pain interference section measuring how pain impacts various aspects of daily life, including mood, sleep, work and social activities (score range 0-70, higher scores mean a worse outcome).
Measured: at baseline, 12 and 24 weeks follow-up
Physical functioning
Evaluated with the PROMIS Short Form v2.0 Physical Function 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome).
Measured: at baseline, 12 and 24 weeks follow-up
Self-reported physical activity
Self-reported levels of physical activity are measured using the Godin-Shephard Leisure-Time Physical Activity Questionnaire.
Measured: at baseline, 12 and 24 weeks follow-up
Objective physical activity
Minutes spent in different intensity zones (sedentary, light, moderate, vigorous) will be collected using a Fitbit device.
Measured: at baseline, 12 and 24 weeks follow-up
Fatigue
Evaluated with the Multidimensional Fatigue Inventory (score range 20-100, higher scores mean a worse outcome).
Measured: at baseline, 12 and 24 weeks follow-up
Sleep disturbance
Evaluated with the PROMIS Short Form v1.0 Sleep Disturbance 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome).
Measured: at baseline, 12 and 24 weeks follow-up
Depression
Evaluated with the PROMIS Short Form v1.0 Depression 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome).
Measured: at baseline, 12 and 24 weeks follow-up
Anxiety
Evaluated with the PROMIS Short Form v1.0 Anxiety 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome).
Measured: at baseline, 12 and 24 weeks follow-up
Social participation
Evaluated with the PROMIS Short Form v2.0 Ability to participate in social roles and activities 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome).
Measured: at baseline, 12 and 24 weeks follow-up
Support
Evaluated with the PROMIS Short Form v2.0 Emotional support 4a, PROMIS Short Form v2.0 Instrumental support 4a and PROMIS Short Form v2.0 Informational support 4a questionnaires (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome).
Measured: at baseline, 12 and 24 weeks follow-up
Cognitive function
Evaluated with the Cognitive Failure Questionnaire (score range 0-100, higher scores mean a worse outcome).
Measured: at baseline, 12 and 24 weeks follow-up
Health-related quality of life
Evaluated with the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire, including the index score (based on the Belgian value set) and the EQ VAS (range 0-100), with higher scores indicating better health outcomes.
Measured: at baseline, 12 and 24 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start10 Nov 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Peripheral Neuropathy (CIPN)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, Griffith University, Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
- Responsible party
- Principal investigator, Lore Dams, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913958
- Sponsor's protocol ID
- B3002026000095
- Other IDs
- 1271925N, 8751 - CTMS 005140, S72537
- Acronym
- CIPN-NEXT
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data are not openly available and are available from the principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
- ClinicalTrials.gov ID
- NCT07913958
- Acronym / sponsor ID
- CIPN-NEXT / B3002026000095
- Keywords
- chemotherapy induced peripheral neuropathy, exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, Griffith University, Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 3 Nov 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 potentially persistent side effect of neurotoxic chemotherapy, characterized by symptoms such as numbness, tingling, pain, and sensory dysfunction in the hands and feet. These symptoms may negatively affect physical functioning, quality of life, and participation in daily activities.
Exercise therapy has emerged as a promising non-pharmacological intervention for individuals with CIPN. However, it remains unclear which exercise approach is most effective. Neurodynamic interventions have shown beneficial effects in other peripheral neuropathic conditions but have not yet been adequately investigated in individuals with CIPN.
The objective of the CIPN-NEXT trial is to evaluate the effectiveness of two exercise-based rehabilitation programmes in individuals with CIPN. Participants will be randomized to one of three study arms: (1) aerobic and resistance exercise, (2) aerobic and resistance exercise combined with neurodynamic interventions, or (3) a wait-list control group.
The study aims to determine whether the addition of neurodynamic interventions provides additional benefit beyond exercise therapy alone with regard to CIPN symptoms, physical functioning, psychosocial functioning, and quality of life. Furthermore, the study will explore potential underlying mechanisms associated with symptom development and recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise program 1: aerobic + resistance training | Active comparator | Behavioral: Exercise program 1: aerobic + resistance trainingParticipants receive advice on physical activity and an activity tracker to monitor physical activity levels, in addition they receive a 12-week individually tailored exercise program consisting of aerobic and resistance training. |
| Exercise program 2: aerobic + resistance training combined with neurodynamic exercises | Experimental | Behavioral: Exercise program 2: aerobic + resistance training combined with neurodynamic exercisesParticipants receive advice on physical activity and an activity tracker to monitor physical activity levels, in addition they receive a 12-week individually tailored exercise program consisting of aerobic training, resistance training and neurodynamic exercises. Neurodynamic exercises are integrated within the exercise program and are progressively adapted according to symptom response. |
| Wait-list control | No intervention | –Participants receive advice on physical activity and an activity tracker to monitor physical activity levels. After 12 weeks, participants are offered the opportunity to participate in Exercise Program 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 18 years
- Primary diagnosis of breast, colon or gynaecological cancer
- Undergoing taxane- or oxaliplatin-based chemotherapy, or having completed this treatment within the previous 3 months
- At least one self-reported symptom consistent with chemotherapy-induced peripheral neuropathy, including numbness, tingling and/or pain in a stocking (feet) and/or glove (hand) distribution, as assessed by the EORTC QLQ-CIPN20 sensory subscale, which emerged during the current course of neurotoxic chemotherapy or within 3 months following its completion
Key exclusion criteria (7 listed)
- Pre-existing peripheral neuropathy or neurological conditions that could account for the reported symptoms, including persistent CIPN from a previous chemotherapy regimen, radiculopathy, entrapment neuropathies, or other non-chemotherapy-related neuropathies
- An Eastern Cooperative Oncology Group (ECOG) performance status above one
- Life expectancy of less than six months according to the patient's oncologist or designee
- Any medical condition that contraindicates safe participation in a low- to moderate-intensity aerobic and resistance exercise program
- Meeting current physical activity guidelines (>150 min/week of moderate-to-vigorous physical activity) or participation in a structured exercise program comparable to the study intervention
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 program 1: aerobic + resistance training* 30-minute face-to-face session with physiotherapist outlining the state of the science on the importance and benefits of physical activity during and after cancer treatment and advising patients to engage in regular physical activity according to the general guidelines * Activity tracker * 12-week individually tailored exercise program * Supervised and home-based aerobic exercise, 5 times per week at moderate intensity * Supervised resistance exercises, 2 times per week | Behavioural | Exercise program 1: aerobic + resistance training |
| Exercise program 2: aerobic + resistance training combined with neurodynamic exercises* 30-minute face-to-face session with physiotherapist outlining the state of the science on the importance and benefits of physical activity during and after cancer treatment and advising patients to engage in regular physical activity according to the general guidelines * Activity tracker * 12-week individually tailored exercise program * Supervised and home-based aerobic exercise, 5 times per week at moderate intensity * Supervised resistance exercises, 2 times per week * Supervised and home-based neurodynamic exercises, 5 times per week | Behavioural | Exercise program 2: aerobic + resistance training combined with neurodynamic exercises |
Primary outcome
Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity
Time frame: at 12 weeks follow-up
To evaluate the primary outcome sensory symptoms of CIPN, the Quality of Life Questionnaire-CIPN twenty-item scale will be used (QLQ-CIPN20 sensory subscale, score range from 9 to 36, higher scores indicating more sensory symptoms or problems).
15 secondary outcomes
Chemotherapy-induced peripheral neuropathy (CIPN) sensory, motor and autonomic symptom severity
Time frame: at baseline, 4, 8, 12 and 24 weeks follow-up
Chemotherapy-induced peripheral neuropathy (CIPN) signs
Time frame: at baseline, 12 and 24 weeks follow-up
Pain severity hands and feet
Time frame: at baseline, 4, 8, 12 and 24 weeks follow-up
General pain location and interference
Time frame: at baseline, 12 and 24 weeks follow-up
Physical functioning
Time frame: at baseline, 12 and 24 weeks follow-up
Self-reported physical activity
Time frame: at baseline, 12 and 24 weeks follow-up
Objective physical activity
Time frame: at baseline, 12 and 24 weeks follow-up
Fatigue
Time frame: at baseline, 12 and 24 weeks follow-up
Sleep disturbance
Time frame: at baseline, 12 and 24 weeks follow-up
Depression
Time frame: at baseline, 12 and 24 weeks follow-up
Anxiety
Time frame: at baseline, 12 and 24 weeks follow-up
Social participation
Time frame: at baseline, 12 and 24 weeks follow-up
Support
Time frame: at baseline, 12 and 24 weeks follow-up
Cognitive function
Time frame: at baseline, 12 and 24 weeks follow-up
Health-related quality of life
Time frame: at baseline, 12 and 24 weeks follow-up
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data are not openly available and are available from the principal investigator upon reasonable request.
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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.
Mira Meeus, Prof. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program 1: aerobic + resistance training and Exercise program 2: aerobic + resistance training combined with neurodynamic exercises in people with Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Universiteit Antwerpen at 2 sites in Belgium.
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 7 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 Lore Dams, Dr. (+32 3 265 16 59, lore.dams@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity (time frame: at 12 weeks follow-up). 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 3 Nov 2026.