NCT07481149 Trial of a Virtual Exercise-based Rehabilitation Program to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
| NCT ID | NCT07481149 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Health Network, Toronto |
| Condition | Chemotherapy-induced Peripheral Neuropathy (CIPN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 240 participants in total. It began in 2026-03-30 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07481149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy-induced Peripheral Neuropathy (CIPN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07481149 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 240 participants.
Is NCT07481149 currently recruiting?
Yes, NCT07481149 is actively recruiting participants. Contact the research team at eric.antonen2@uhn.ca for enrollment information.
Where is the NCT07481149 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07481149 clinical trial?
NCT07481149 is sponsored by University Health Network, Toronto. The trial plans to enroll 240 participants.