Trial of a Virtual Exercise-based Rehabilitation Program to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)

A Pragmatic Randomized Controlled Trial of a Virtual Exercise-based Rehabilitation Intervention for Persistent Chemotherapy-Induced Peripheral Neuropathy (EX-CIPN).

Trial of a Virtual Exercise-based Rehabilitation Program to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN) (NCT07481149) is a Phase 3 interventional studying Chemotherapy-induced Peripheral Neuropathy (CIPN), sponsored by University Health Network, Toronto. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Chemotherapy-induced Peripheral Neuropathy (CIPN), Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 240 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chemotherapy-induced Peripheral Neuropathy (CIPN) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments Being Tested

BEHAVIORAL

EX-CIPN

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

ELLICSR: Health Wellness and Cancer Survivorship Centre

Toronto, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07481149), the sponsor (University Health Network, Toronto), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07481149 clinical trial studying?

Who can participate in NCT07481149?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07481149?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07481149. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07481149. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.