Chemotherapy-induced Peripheral Neuropathy (CIPN)Phase 3EX-CIPNNCT07481149
Trial of a Virtual Exercise-based Rehabilitation Program to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
A Phase 3 study testing EX-CIPN in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effectiveness of the EX-CIPN program in reducing the strength of CIPN symptoms and CIPN-related disability and improving the ability to complete everyday activities. 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?
- EX-CIPN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2026to Jul 2029
- Phase
- Phase 3
- 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
- diagnosed with any type of cancer
- received chemotherapy treatment as part of curative-intent therapy (no minimum dose)
- >6 months following chemotherapy completion with no current plans for further chemotherapy
- report Grade 1 or higher on the numbness and tingling severity item of the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
- neuropathic pain 3 or higher on the Neuropathic Pain 4 (DN4) (interview)
- capable of ambulation and transfers (with or without gait/transfer aid) (ECOG score 0-2)
- are able to communicate sufficiently in English to complete intervention, questionnaires, and consent
- have access to and able to operate videoconferencing
Who cannot join
- currently meeting all recommendations from the physical activity guidelines for cancer survivors
- have any neurological conditions influencing cognition (i.e. dementia, Alzheimer's) and preventing safe or appropriate engagement with exercise recommendation
- have neuropathy that pre-existed chemotherapy receipt (i.e. diabetic neuropathy)
- currently enrolled in other rehabilitation or exercise-based interventions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
ELLICSR: Health Wellness and Cancer Survivorship Centre
Toronto, Ontario, M5G 2N2
Eric Antonen, MSc, 416-634-7784, eric.antonen2@uhn.ca
About this study
Official title: A Pragmatic Randomized Controlled Trial of a Virtual Exercise-based Rehabilitation Intervention for Persistent Chemotherapy-Induced Peripheral Neuropathy (EX-CIPN).
The purpose of this study is to determine the effectiveness of the EX-CIPN program in reducing the strength of CIPN symptoms and CIPN-related disability and improving the ability to complete everyday activities. This will be done by determining whether it is better to receive the EX-CIPN program or better to receive no additional intervention. To do this, some of the participants in this study will get EX-CIPN and others will receive usual care. Those who receive usual care will be offered EX-CIPN upon study completion. The main question it aims to answer is:
- Is EX-CIPN effective in improving CIPN symptoms for cancer survivors experiencing persistent CIPN?
Read more
Participants in both study groups will be asked to:
- Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention
Participants in the EX-CIPN group will be asked to:
- Complete an additional aassessment at 6-months post-intervention
- Complete a 10-week remote, individualized exercise program
- Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention
- Wear a FitBit throughout the study to track physical activity and promote behaviour change
- Being tested
- EX-CIPN
- Keywords
- cancer rehabilitation, peripheral neuropathy, randomized controlled trial
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EX-CIPNBehavioural
The 10-week intervention includes: Individualized Exercise Program: Each participant will receive an individualized progressive exercise program that includes cardiovascular and strength training as well as balance and desensitization exercises specific to CIPN symptoms. Remote Monitoring: Fitbit™ devices will be used to monitor patients' physical activity over the duration of the program. Fitness trackers can promote behaviour change. Remote Person-to-Person Clinical Support: Participants will have scheduled remote check-ins and health coaching sessions with their assigned RKin on weeks 2, 3, 4, 6, and 8 of the intervention. During these calls, the RKin will progress the exercise program as needed, discuss and develop goals, and identify potential barriers and solutions in achieving their goals.
After the 10-week intervention participants will receive a 3-month maintenance phase with 2 monthly remote check-ins.
| Study group | Role | What they receive |
|---|---|---|
| EX-CIPN Exercise-based Intervention | Experimental | This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support. Receives: Behavioral: EX-CIPN |
| Usual Care Control | No intervention | This arm is provided usual oncology care and is provided the intervention after completing all study assessments (5-6 months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIPN Symptoms
Measured using the European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy (EORTC CIPN-20) questionnaire. Results are scored on a scale between 20-80 with higher scores meaning worse outcomes.
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Secondary outcomes (6)
CIPN-related disability
Measured using the Rasch-built Overall Disability Scale for patients with chemotherapy-induced peripheral neuropathy CIPN-R-ODS. Results are scored on a scale between 0-56 with lower scores meaning worse outcomes.
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Strength (Upper Body)
Measured via handgrip dynamometry or grip strength test (GST).
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Strength (Lower Body)
Measured by a 30-second sit to stand test (30-s STS).
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Balance
Measured using the 7-Item Berg Balance Test. The test provides a score from 0 to 28 with lower scores meaning worse outcomes.
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Gait Speed
Measured using the Four-Metre Gait Speed Test.
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Aerobic Functional Capacity
Measured using a 6-minute walk test (6MWT).
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start30 Mar 2026
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (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.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic, parallel group, two-arm, single-blind, randomized controlled trial (pRCT)
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481149
- Sponsor's protocol ID
- 25-5957
- Acronym
- EX-CIPN
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial of a Virtual Exercise-based Rehabilitation Intervention for Persistent Chemotherapy-Induced Peripheral Neuropathy (EX-CIPN).
- ClinicalTrials.gov ID
- NCT07481149
- Acronym / sponsor ID
- EX-CIPN / 25-5957
- Keywords
- cancer rehabilitation, peripheral neuropathy, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 18 Mar 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.
The purpose of this study is to determine the effectiveness of the EX-CIPN program in reducing the strength of CIPN symptoms and CIPN-related disability and improving the ability to complete everyday activities. This will be done by determining whether it is better to receive the EX-CIPN program or better to receive no additional intervention. To do this, some of the participants in this study will get EX-CIPN and others will receive usual care. Those who receive usual care will be offered EX-CIPN upon study completion. The main question it aims to answer is:
- Is EX-CIPN effective in improving CIPN symptoms for cancer survivors experiencing persistent CIPN?
Participants in both study groups will be asked to:
- Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention
Participants in the EX-CIPN group will be asked to:
- Complete an additional aassessment at 6-months post-intervention
- Complete a 10-week remote, individualized exercise program
- Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention
- Wear a FitBit throughout the study to track physical activity and promote behaviour change
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A pragmatic, parallel group, two-arm, single-blind, randomized controlled trial (pRCT)
| Arm | Type | Receives |
|---|---|---|
| EX-CIPN Exercise-based Intervention | Experimental | Behavioral: EX-CIPNThis arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support. |
| Usual Care Control | No intervention | –This arm is provided usual oncology care and is provided the intervention after completing all study assessments (5-6 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosed with any type of cancer
- received chemotherapy treatment as part of curative-intent therapy (no minimum dose)
- >6 months following chemotherapy completion with no current plans for further chemotherapy
- report Grade 1 or higher on the numbness and tingling severity item of the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
- neuropathic pain 3 or higher on the Neuropathic Pain 4 (DN4) (interview)
Key exclusion criteria (4 listed)
- currently meeting all recommendations from the physical activity guidelines for cancer survivors
- have any neurological conditions influencing cognition (i.e. dementia, Alzheimer's) and preventing safe or appropriate engagement with exercise recommendation
- have neuropathy that pre-existed chemotherapy receipt (i.e. diabetic neuropathy)
- currently enrolled in other rehabilitation or exercise-based interventions
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 |
|---|---|---|
| EX-CIPNThe 10-week intervention includes: Individualized Exercise Program: Each participant will receive an individualized progressive exercise program that includes cardiovascular and strength training as well as balance and desensitization exercises specific to CIPN symptoms. Remote Monitoring: Fitbit™ devices will be used to monitor patients' physical activity over the duration of the program. Fitness trackers can promote behaviour change. Remote Person-to-Person Clinical Support: Participants will have scheduled remote check-ins and health coaching sessions with their assigned RKin on weeks 2, 3, 4, 6, and 8 of the intervention. During these calls, the RKin will progress the exercise program as needed, discuss and develop goals, and identify potential barriers and solutions in achieving their goals. After the 10-week intervention participants will receive a 3-month maintenance phase with 2 monthly remote check-ins. | Behavioural | EX-CIPN Exercise-based Intervention |
Primary outcome
CIPN Symptoms
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Measured using the European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy (EORTC CIPN-20) questionnaire. Results are scored on a scale between 20-80 with higher scores meaning worse outcomes.
6 secondary outcomes
CIPN-related disability
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Strength (Upper Body)
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Strength (Lower Body)
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Balance
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Gait Speed
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
Aerobic Functional Capacity
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
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 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EX-CIPN in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by University Health Network, Toronto at 1 site in Canada.
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 8 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: looking for participants now, as of the sponsor's last update on 5 Jun 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eric Antonen, MSc (416-634-7784, eric.antonen2@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIPN Symptoms (time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)). 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 5 Jun 2026.