An interventional study of Exercise program 1: aerobic + resistance training and Exercise program 2: aerobic + resistance training combined with neurodynamic exercises in Chemotherapy Induced Peripheral Neuropathy (CIPN), sponsored by Universiteit Antwerpen. Not yet recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Universiteit Antwerpen · Not applicable, Interventional, and Supportive care
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.
2,684 studies on the registry are indexed under Motor Activity; 1,217 are open to participants now.
This study's planned enrollment of 87 is above the median of 60 across 2,344 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Universiteit Antwerpen is the lead sponsor of 135 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Exercise program 1: aerobic + resistance training
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.
Behavioral: Exercise program 2: aerobic + resistance training combined with neurodynamic exercises
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.
* 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
* 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
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).
Time frame: at 12 weeks follow-up
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: at baseline, 12 and 24 weeks follow-up
Compliance - adherence to exercise intervention
Evaluated with a self-composed questionnaire.
Time frame: From enrollment to the end of the intervention period at 12 weeks]
Beliefs about the efficacy of treatment
Evaluated with the Patient Global Impression of Change questionnaire (score range 1-7, higher scores mean a worse outcome).
Time frame: at 12 weeks follow-up
Safety of exercise intervention
Evaluated with a self-composed questionnaire.
Time frame: From enrollment to the end of the intervention period at 12 weeks
Patient experiences with exercise intervention
Evaluated with a self-composed questionnaire.
Time frame: at 12 weeks follow-up
Medication use
Self-composed questionnaire.
Time frame: at baseline, 4, 8, 12 and 24 weeks follow-up
Supportive care
Self-composed questionnaire.
Time frame: at baseline, 4, 8, 12 and 24 weeks follow-up
Body Mass Index (BMI)
BMI (kg/m²) will be calculated based on height (measured using a stadiometer) and weight (measured with the InBody 770 device).
Time frame: at 12 and 24 weeks follow-up
Body composition
Measured with the InBody 770 device
Time frame: at baseline, 12 and 24 weeks follow-up
Plan to share: Yes — The data are not openly available and are available from the principal investigator upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: On request
Access criteria: On request
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2028, 20 months later.
Of 1,755 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 46. This study's planned 20 months is below that.
Counting every sponsor, half of 1,767 studies reached it within 23 months; a quarter within 9 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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