← Back to all trials
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
Source: ClinicalTrials.gov (NCT07481149). StuddyBuddy aggregates publicly available trial information.