Chemotherapy-induced Peripheral NeuropathyPhase 1EX-CIPNNCT06405542
Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)
A Phase 1 study testing EX-CIPN in people with Chemotherapy-induced Peripheral Neuropathy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (CIPN). It will also give insight on the effectiveness of the exercise intervention in treating CIPN symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- 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
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 25 Apr 2024to 20 Jun 2026
- Phase
- Phase 1
- 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
- Received a diagnosis of any cancer and treated with curative intent (no minimum dose) including Stage 3 \& 4 gynecologic malignancies, treated in the platinum-sensitive setting
- Are > 6 months post-completion of chemotherapy (ie no other chemotherapeutic agents since completing of the chemotherapy regimen)
- Report > Grade 1 on the Patient Reported NCI Common Terminology Criteria for Adverse Events version 5.0 grading scale (numbness and tingling severity item) and neuropathic pain >3 on the Neuropathic Pain 4 (DN4) (interview) (0-7)
- The presence of peripheral neuropathy due to chemotherapy (following onset of chemotherapy), as established via clinical assessment
- May be on maintenance oncologic therapies (ie endocrine therapy, Poly (ADP-ribose) polymerase (PARP) inhibitors) not known to cause neuropathy
- No current plans for chemotherapy in the next 6 months
Show all 11Show fewer
- Currently engaging in < 90min per week of planned moderate-intensity aerobic exercise
- Independent with ambulation and transfers with or without ambulatory assistance (EGOG 0-2)
- Able to communicate sufficiently in English to complete intervention, questionnaires, and consent
- Willing to participate in the intervention and attend in-person physical assessments
- Have access to and are able to operate videoconferencing.
Who cannot join
- Known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations
- Pre-existing neuropathy prior to the start of chemotherapy
- Are currently enrolled in other cancer rehabilitation or exercise-based programs/interventions.
- Are currently taking ado-trastuzumab emtansine (TDM1) (ex. Kadcyla)
Trial locations and contacts
1 site in 1 country.
Canada1 site
ELLICSR: Health Wellness and Cancer Survivorship Centre
Toronto, Ontario, M5G 2N2
About this study
Official title: EX-CIPN: An Exercise-based Rehabilitation Intervention to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
The goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (CIPN). It will also give insight on the effectiveness of the exercise intervention in treating CIPN symptoms. The main questions it aims to answer are:
- Is EX-CIPN safe, acceptable, and feasible in cancer survivors experiencing persistent CIPN?
- Are the study design and methods feasible (recruitment and retention rates, feasibility of data collection and procedures)?
Read more
Researchers will provide all participants with the exercise-based intervention.
Participants will:
- Complete assessments at baseline, immediately post-intervention, and 3-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
- 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 and will be adjusted to the needs of the patient.
Remote Monitoring: Fitbit™ devices will be used to monitor patients' physical activity over the duration of the program. Fitness trackers can promote behaviour change and allows for self-monitoring and feedback to the participant.
Remote Person-to-Person Clinical Support: Participants will have scheduled remote check-ins and health coaching sessions with their assigned RKin over Microsoft Teams (MSTeams) on weeks 2, 3, 4, 6, and 8 of the intervention. During these calls, the RKin will review, adapt, and progress the exercise program as needed, discuss and develop goals for the following week, and identify potential barriers and solutions in achieving their goals.
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual Rate
Assessed based on CONSORT criteria through a screening log that tracks data collected of all screened patients. Eligibility screening will be performed to identify eligible consented and eligible non-recruited individuals with non-recruitment reasons documented. Number of participants consented and enrolled will be tracked each month.
Measured: Throughout study completion, up to 24 weeks.
Retention Rates
Retention rates will be calculated as the proportion of participants that attend each assessment time point. The investigators will also examine rates of complete and missing data.
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Adherence
Assessed through health coaching call attendance, Fitbit™ usage, and self-report completion of weekly exercise plan
Measured: Through study completion, up to 24 weeks.
Intervention Safety
All adverse events will be scored on the CTCAE version 5.0 and documented during weekly appointments and at follow-up assessments with the Registered Kinesiologist (RKin). Assessment, tests, and all exercises will be stopped at any time if any pain or discomfort is experienced.
Measured: Through study completion, up to 24 weeks.
Secondary outcomes (8)
Pain Intensity
Measured using the numeric pain rating scale (NPRS). Scored on a 1-10 scale, 1 being no pain and 10 being worst pain imaginable.
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
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 (20-24 weeks)
CIPN-related Disability
Measured using the Rasch-built Overall Disability Scale for patients with chemotherapy-induced peripheral neuropathy CIPN-RODS. 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 (20-24 weeks)
Strength (Upper Body)
Measured via handgrip dynamometry or grip strength test (GST).
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 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 (20-24 weeks)
Balance
Measured using the Short Physical Performance Battery (SPPB) Balance Test. The SPPB balance test provides a score from 0 to 4 with lower scores meaning worse outcomes.
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Gait Speed
Measured using the Four-Metre Gait Speed Test.
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Aerobic Functional Capacity
Measured using a 6-minute walk test (6MWT).
Measured: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start25 Apr 2024
- Primary completion20 Mar 2026
- Study completion20 Jun 2026 (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 NeuropathyStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research Society, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405542
- Sponsor's protocol ID
- 23-5839
- Acronym
- EX-CIPN
- Status last verified
- Jun 2026
- First submitted
- 2 May 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EX-CIPN: An Exercise-based Rehabilitation Intervention to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
- ClinicalTrials.gov ID
- NCT06405542
- Acronym / sponsor ID
- EX-CIPN / 23-5839
- Keywords
- Cancer Rehabilitation, Peripheral Neuropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Cancer Research Society, Canadian Institutes of Health Research (CIHR)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 8 May 2024 (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 goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (CIPN). It will also give insight on the effectiveness of the exercise intervention in treating CIPN symptoms. The main questions it aims to answer are:
- Is EX-CIPN safe, acceptable, and feasible in cancer survivors experiencing persistent CIPN?
- Are the study design and methods feasible (recruitment and retention rates, feasibility of data collection and procedures)?
Researchers will provide all participants with the exercise-based intervention.
Participants will:
- Complete assessments at baseline, immediately post-intervention, and 3-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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Received a diagnosis of any cancer and treated with curative intent (no minimum dose) including Stage 3 \& 4 gynecologic malignancies, treated in the platinum-sensitive setting
- Are > 6 months post-completion of chemotherapy (ie no other chemotherapeutic agents since completing of the chemotherapy regimen)
- Report > Grade 1 on the Patient Reported NCI Common Terminology Criteria for Adverse Events version 5.0 grading scale (numbness and tingling severity item) and neuropathic pain >3 on the Neuropathic Pain 4 (DN4) (interview) (0-7)
- The presence of peripheral neuropathy due to chemotherapy (following onset of chemotherapy), as established via clinical assessment
- May be on maintenance oncologic therapies (ie endocrine therapy, Poly (ADP-ribose) polymerase (PARP) inhibitors) not known to cause neuropathy
Key exclusion criteria (4 listed)
- Known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations
- Pre-existing neuropathy prior to the start of chemotherapy
- Are currently enrolled in other cancer rehabilitation or exercise-based programs/interventions.
- Are currently taking ado-trastuzumab emtansine (TDM1) (ex. Kadcyla)
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 and will be adjusted to the needs of the patient. Remote Monitoring: Fitbit™ devices will be used to monitor patients' physical activity over the duration of the program. Fitness trackers can promote behaviour change and allows for self-monitoring and feedback to the participant. Remote Person-to-Person Clinical Support: Participants will have scheduled remote check-ins and health coaching sessions with their assigned RKin over Microsoft Teams (MSTeams) on weeks 2, 3, 4, 6, and 8 of the intervention. During these calls, the RKin will review, adapt, and progress the exercise program as needed, discuss and develop goals for the following week, and identify potential barriers and solutions in achieving their goals. | Behavioural | EX-CIPN Exercise- Based intervention |
Primary outcome
Accrual Rate
Time frame: Throughout study completion, up to 24 weeks.
Assessed based on CONSORT criteria through a screening log that tracks data collected of all screened patients. Eligibility screening will be performed to identify eligible consented and eligible non-recruited individuals with non-recruitment reasons documented. Number of participants consented and enrolled will be tracked each month.
Retention Rates
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Retention rates will be calculated as the proportion of participants that attend each assessment time point. The investigators will also examine rates of complete and missing data.
Adherence
Time frame: Through study completion, up to 24 weeks.
Assessed through health coaching call attendance, Fitbit™ usage, and self-report completion of weekly exercise plan
Intervention Safety
Time frame: Through study completion, up to 24 weeks.
All adverse events will be scored on the CTCAE version 5.0 and documented during weekly appointments and at follow-up assessments with the Registered Kinesiologist (RKin). Assessment, tests, and all exercises will be stopped at any time if any pain or discomfort is experienced.
8 secondary outcomes
Pain Intensity
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
CIPN Symptoms
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
CIPN-related Disability
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Strength (Upper Body)
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Strength (Lower Body)
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Balance
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Gait Speed
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)
Aerobic Functional Capacity
Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 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 4 Jun 2026.
Related trials for Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EX-CIPN in people with Chemotherapy-induced Peripheral Neuropathy, 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 11 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: under way, not looking for participants, as of the sponsor's last update on 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual Rate (time frame: Throughout study completion, up to 24 weeks.). The study lists 4 primary outcomes in all. 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 4 Jun 2026.