Chemotherapy Induced Peripheral Neuropathy (CIPN)CIPN-EXNCT06962579
The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy
A study testing Exercise intervention 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 debilitating and common side effect of neurotoxic cancer treatment. The most frequent symptoms include sensory disturbances and weakness in the hands and/or feet. CIPN can interfere with both daily activities and cancer treatment itself. 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 intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesBelgium
- Study dates
- 5 Jun 2025to 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
- a primary diagnosis of breast, gynaecological or colon cancer, without distant metastasis
- been chemotherapy naïve
- been scheduled for at least 12 weeks of taxane- or platinum-based chemotherapy without other neurotoxic chemotherapy
Who cannot join
- life expectancy of less than six months according to the patient's oncologist or designee
- advanced stage of disease
- having a known current neuropathy
- having cognitive or physical limitations that contraindicate participation in a low- to moderate intensity home-based walking and progressive resistance program (determined by the patient's oncologist)
- not able to read and understand Dutch
- not able to provide informed consent
- not able to participate during the entire study period
- pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Prof. An De Groef contact
Belgium2 sites, 2 recruiting
- Recruiting
Antwerp University Hospital
Edegem, 2650
Dr. Lore Dams, +32 3 265 16 59, lore.dams@uantwerpen.be
- Recruiting
University Hospital Leuven
Leuven, 3000
Dr. Lore Dams, +32 3 265 16 59, lore.dams@uzleuven.be
About this study
Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and common side effect of neurotoxic cancer treatment. The most frequent symptoms include sensory disturbances and weakness in the hands and/or feet. CIPN can interfere with both daily activities and cancer treatment itself. Although there is proof of concept for physical activity as a preventive measure for CIPN, physical activity is currently not included in the international evidence-based guideline for the prevention of CIPN due to the need of larger sample-sized definitive studies. The aim of this project is, on the one hand, to investigate the preventive effect of an exercise program based on international physical activity guidelines on CIPN symptoms in patients with breast or colorectal cancer undergoing taxane- or platinum-based chemotherapy. On the other hand, the study will also explore how patients and healthcare professionals experience the implementation of physical activity during this phase of therapy. A prospective randomized controlled trial will be conducted, with CIPN symptoms as the primary outcome measure.
Read the detailed description
The scientific goals of the project are:
- The primary scientific objective of the study is to determine the effect of a patient-tailored exercise program based on exercise guidelines in oncology on sensory symptoms of CIPN (QLQ-CIPN20, sensory subscale) at short term (12 weeks) compared to usual care.
- The secondary scientific objectives entail to examine if the exercise program has beneficial short (i.e., 12 weeks) and- or long term (i.e., 24 weeks) effects on symptoms of CIPN (QLQ-CIPN20, motor and autonomic subscale) and other biopsychosocial outcomes related to CIPN: (1) Signs of CIPN, (2) Physical functioning, (3) Psychosocial functioning, and (4) Relative dose intensity of chemotherapy.
- The tertiary objective of this study is to perform a process evaluation. The aim of this process evaluation is to investigate the barriers and facilitators of the exercise program in patients receiving taxane- or platinum-based chemotherapy by examining adherence to the exercise program as well as how patients and healthcare providers perceive the implementation of the exercise program.
- Being tested
- Exercise intervention
- 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 interventionBehavioural
- 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
- 12-week individually tailored exercise program
- Home-based aerobic exercise, 3 times per week at moderate intensity
- Supervised resistance and sensorimotor exercises, 2 times per week
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Participants receive a 12-week individually tailored exercise program from the start of taxane- or platinum-based chemotherapy, in addition to the standard of care (advice on physical activity during cancer treatment) Receives: Behavioral: Exercise intervention |
| No formal exercise intervention | No intervention | Standard of care (advice on physical activity during cancer treatment) |
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 (16)
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 4, 8, 12 and 24 weeks follow-up
Relative dose intensity chemotherapy (%)
Relative Dose Intensity (RDI) of chemotherapy, calculated as the ratio of delivered dose intensity to the planned dose intensity, expressed as a percentage.
Measured: at 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).
Measured: at 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 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 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 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 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 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 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 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 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 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 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 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 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 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 posted8 May 2025
- Study start5 Jun 2025
- Primary completion1 Jul 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
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, Kom Op Tegen Kanker
- Responsible party
- Principal investigator, Lore Dams, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962579
- Sponsor's protocol ID
- 6776
- Other IDs
- Edge 3857, S69491
- Acronym
- CIPN-EX
- Status last verified
- Jul 2025
- First submitted
- 13 Apr 2025
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06962579
- Acronym / sponsor ID
- CIPN-EX / 6776
- Keywords
- chemotherapy induced peripheral neuropathy, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, Kom Op Tegen Kanker
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 8 May 2025 (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 debilitating and common side effect of neurotoxic cancer treatment. The most frequent symptoms include sensory disturbances and weakness in the hands and/or feet. CIPN can interfere with both daily activities and cancer treatment itself. Although there is proof of concept for physical activity as a preventive measure for CIPN, physical activity is currently not included in the international evidence-based guideline for the prevention of CIPN due to the need of larger sample-sized definitive studies. The aim of this project is, on the one hand, to investigate the preventive effect of an exercise program based on international physical activity guidelines on CIPN symptoms in patients with breast or colorectal cancer undergoing taxane- or platinum-based chemotherapy. On the other hand, the study will also explore how patients and healthcare professionals experience the implementation of physical activity during this phase of therapy. A prospective randomized controlled trial will be conducted, with CIPN symptoms as the primary outcome measure.
Detailed description
The scientific goals of the project are:
- The primary scientific objective of the study is to determine the effect of a patient-tailored exercise program based on exercise guidelines in oncology on sensory symptoms of CIPN (QLQ-CIPN20, sensory subscale) at short term (12 weeks) compared to usual care.
- The secondary scientific objectives entail to examine if the exercise program has beneficial short (i.e., 12 weeks) and- or long term (i.e., 24 weeks) effects on symptoms of CIPN (QLQ-CIPN20, motor and autonomic subscale) and other biopsychosocial outcomes related to CIPN: (1) Signs of CIPN, (2) Physical functioning, (3) Psychosocial functioning, and (4) Relative dose intensity of chemotherapy.
- The tertiary objective of this study is to perform a process evaluation. The aim of this process evaluation is to investigate the barriers and facilitators of the exercise program in patients receiving taxane- or platinum-based chemotherapy by examining adherence to the exercise program as well as how patients and healthcare providers perceive the implementation of the exercise program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Exercise interventionParticipants receive a 12-week individually tailored exercise program from the start of taxane- or platinum-based chemotherapy, in addition to the standard of care (advice on physical activity during cancer treatment) |
| No formal exercise intervention | No intervention | –Standard of care (advice on physical activity during cancer treatment) |
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
- a primary diagnosis of breast, gynaecological or colon cancer, without distant metastasis
- been chemotherapy naïve
- been scheduled for at least 12 weeks of taxane- or platinum-based chemotherapy without other neurotoxic chemotherapy
Key exclusion criteria (8 listed)
- life expectancy of less than six months according to the patient's oncologist or designee
- advanced stage of disease
- having a known current neuropathy
- having cognitive or physical limitations that contraindicate participation in a low- to moderate intensity home-based walking and progressive resistance program (determined by the patient's oncologist)
- not able to read and understand Dutch
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 intervention* 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 * 12-week individually tailored exercise program * Home-based aerobic exercise, 3 times per week at moderate intensity * Supervised resistance and sensorimotor exercises, 2 times per week | Behavioural | Exercise intervention |
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).
16 secondary outcomes
Chemotherapy-induced peripheral neuropathy (CIPN) sensory, motor and autonomic symptom severity
Time frame: at 4, 8, 12 and 24 weeks follow-up
Relative dose intensity chemotherapy (%)
Time frame: at 4, 8, 12 and 24 weeks follow-up
Chemotherapy-induced peripheral neuropathy (CIPN) signs
Time frame: at 12 and 24 weeks follow-up
Pain severity hands and feet
Time frame: at 12 and 24 weeks follow-up
General pain location and interference
Time frame: at 12 and 24 weeks follow-up
Physical functioning
Time frame: at 12 and 24 weeks follow-up
Self-reported physical activity
Time frame: at 12 and 24 weeks follow-up
Objective physical activity
Time frame: at 12 and 24 weeks follow-up
Fatigue
Time frame: at 12 and 24 weeks follow-up
Sleep disturbance
Time frame: at 12 and 24 weeks follow-up
Depression
Time frame: at 12 and 24 weeks follow-up
Anxiety
Time frame: at 12 and 24 weeks follow-up
Social participation
Time frame: at 12 and 24 weeks follow-up
Support
Time frame: at 12 and 24 weeks follow-up
Cognitive function
Time frame: at 12 and 24 weeks follow-up
Health-related quality of life
Time frame: at 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 9 Jul 2025.
- 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.
Prof. An De Groef 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 intervention 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 8 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: looking for participants now, as of the sponsor's last update on 9 Jul 2025. 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 Dr. Lore Dams (+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 9 Jul 2025.