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

NCT07481149 | Recruiting Phase 3

• 1 other identifier: 25-5957
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Keywords

cancer rehabilitation; peripheral neuropathy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• CIPN Symptoms

  Measured using the European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy (EORTC CIPN-20) questionnaire. Results are scored on a scale between 20-80 with higher scores meaning worse outcomes.

  Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)

Secondary Outcomes (6)

• CIPN-related disability

  Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)

• Strength (Upper Body)

  Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)

• Strength (Lower Body)

  Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)

• Balance

  Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)

• Gait Speed

  Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)

Study Arms (2)

EX-CIPN Exercise-based Intervention

EXPERIMENTAL

This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support.

Behavioral: EX-CIPN

Usual Care Control

NO INTERVENTION

This arm is provided usual oncology care and is provided the intervention after completing all study assessments (5-6 months)

Interventions

EX-CIPN BEHAVIORAL

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.

EX-CIPN Exercise-based Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

ELLICSR: Health Wellness and Cancer Survivorship Centre

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Eric Antonen, MSc

CONTACT

416-634-7784; eric.antonen2@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic, parallel group, two-arm, single-blind, randomized controlled trial (pRCT)

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

CA (1)