Recruiting
Phase 3

EX-CIPN

Sponsor:

University Health Network, Toronto

Code:

NCT07481149

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EX-CIPN

Study Details

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)

Study ID

NCT07481149

Start date

Mar 30, 2026

Status verified date

Jun, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

EX-CIPN

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 outcome measure

  • CIPN Symptoms [ Time Frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) ]

Central Contacts and Locations

Central contacts

Eric Antonen, MSc

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

Locations

ELLICSR: Health Wellness and Cancer Survivorship Centre

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Eric Antonen, MSc

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • cancer rehabilitation
  • peripheral neuropathy
  • randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-05.