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NCT Number: NCT07481149

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

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

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN) Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ELLICSR: Health Wellness and Cancer Survivorship Centre

Toronto, Ontario, M5G 2N2, Canada

Location status: Recruiting

Location contact

Eric Antonen, MSc

CONTACT

[email protected]

416-634-7784

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. CIPN Symptoms

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

    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.

Secondary outcomes

  1. CIPN-related disability

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

    Measured using the Rasch-built Overall Disability Scale for patients with chemotherapy-induced peripheral neuropathy CIPN-R-ODS. Results are scored on a scale between 0-56 with lower scores meaning worse outcomes.

  2. Strength (Upper Body)

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

    Measured via handgrip dynamometry or grip strength test (GST).

  3. Strength (Lower Body)

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

    Measured by a 30-second sit to stand test (30-s STS).

  4. Balance

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

    Measured using the 7-Item Berg Balance Test. The test provides a score from 0 to 28 with lower scores meaning worse outcomes.

  5. Gait Speed

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

    Measured using the Four-Metre Gait Speed Test.

  6. Aerobic Functional Capacity

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

    Measured using a 6-minute walk test (6MWT).

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Antonen, MSc

CONTACT

[email protected]

416-634-7784

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: EX-CIPN

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 18, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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