Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)

NCT06405542 | Active Not Recruiting Phase 1

• 1 other identifier: 23-5839
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (CIPN). It will also give insight on the effectiveness of the exercise intervention in treating CIPN symptoms. The main questions it aims to answer are:

• Is EX-CIPN safe, acceptable, and feasible in cancer survivors experiencing persistent CIPN?
• Are the study design and methods feasible (recruitment and retention rates, feasibility of data collection and procedures)? Researchers will provide all participants with the exercise-based intervention. Participants will:
• Complete assessments at baseline, immediately post-intervention, and 3-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

Keywords

Cancer Rehabilitation; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (4)

• Accrual Rate

  Assessed based on CONSORT criteria through a screening log that tracks data collected of all screened patients. Eligibility screening will be performed to identify eligible consented and eligible non-recruited individuals with non-recruitment reasons documented. Number of participants consented and enrolled will be tracked each month.

  Throughout study completion, up to 24 weeks.

• Retention Rates

  Retention rates will be calculated as the proportion of participants that attend each assessment time point. The investigators will also examine rates of complete and missing data.

  Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)

• Adherence

  Assessed through health coaching call attendance, Fitbit™ usage, and self-report completion of weekly exercise plan

  Through study completion, up to 24 weeks.

• Intervention Safety

  All adverse events will be scored on the CTCAE version 5.0 and documented during weekly appointments and at follow-up assessments with the Registered Kinesiologist (RKin). Assessment, tests, and all exercises will be stopped at any time if any pain or discomfort is experienced.

  Through study completion, up to 24 weeks.

Secondary Outcomes (8)

• Pain Intensity

  Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)

• CIPN Symptoms

  Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)

• CIPN-related Disability

  Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)

• Strength (Upper Body)

  Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)

• Strength (Lower Body)

  Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks)

Study Arms (1)

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

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 and will be adjusted to the needs of the patient. Remote Monitoring: Fitbit™ devices will be used to monitor patients' physical activity over the duration of the program. Fitness trackers can promote behaviour change and allows for self-monitoring and feedback to the participant. Remote Person-to-Person Clinical Support: Participants will have scheduled remote check-ins and health coaching sessions with their assigned RKin over Microsoft Teams (MSTeams) on weeks 2, 3, 4, 6, and 8 of the intervention. During these calls, the RKin will review, adapt, and progress the exercise program as needed, discuss and develop goals for the following week, and identify potential barriers and solutions in achieving their goals.

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:

• Received a diagnosis of any cancer and treated with curative intent (no minimum dose) including Stage 3 \& 4 gynecologic malignancies, treated in the platinum-sensitive setting
• Are \> 6 months post-completion of chemotherapy (ie no other chemotherapeutic agents since completing of the chemotherapy regimen)
• Report \> Grade 1 on the Patient Reported NCI Common Terminology Criteria for Adverse Events version 5.0 grading scale (numbness and tingling severity item) and neuropathic pain \>3 on the Neuropathic Pain 4 (DN4) (interview) (0-7)
• The presence of peripheral neuropathy due to chemotherapy (following onset of chemotherapy), as established via clinical assessment
• May be on maintenance oncologic therapies (ie endocrine therapy, Poly (ADP-ribose) polymerase (PARP) inhibitors) not known to cause neuropathy
• No current plans for chemotherapy in the next 6 months
• Currently engaging in \< 90min per week of planned moderate-intensity aerobic exercise
• Independent with ambulation and transfers with or without ambulatory assistance (EGOG 0-2)
• Able to communicate sufficiently in English to complete intervention, questionnaires, and consent
• Willing to participate in the intervention and attend in-person physical assessments
• Have access to and are able to operate videoconferencing.

You may not qualify if:

• Known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations
• Pre-existing neuropathy prior to the start of chemotherapy
• Are currently enrolled in other cancer rehabilitation or exercise-based programs/interventions.
• Are currently taking ado-trastuzumab emtansine (TDM1) (ex. Kadcyla)

Sponsors & Collaborators

• Cancer Research Society: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• University Health Network, Toronto: lead

Study Sites (1)

ELLICSR: Health Wellness and Cancer Survivorship Centre

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 8, 2024
• Study Start: April 25, 2024
• Primary Completion: March 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

CA (1)