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Recruiting NCT07481149

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

Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 240
Sponsor: University Health Network, Toronto

Location: ELLICSR: Health Wellness and Cancer Survivorship Centre Toronto Ontario

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07481149). StuddyBuddy aggregates publicly available trial information.