Peripheral Neuropathy Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
ELLICSR: Health Wellness and Cancer Survivorship Centre
RECRUITING
Toronto
Contact Information
Primary
Eric Antonen, MSc
eric.antonen2@uhn.ca
416-634-7784
Time Frame
Start Date: 2026-03-30
Estimated Completion Date: 2029-07
Participants
Target number of participants: 240
Treatments
Experimental: EX-CIPN Exercise-based Intervention
This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support.
No_intervention: Usual Care Control
This arm is provided usual oncology care and is provided the intervention after completing all study assessments (5-6 months)
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov

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