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Active, Not Recruiting

NCT Number: NCT06405542

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ELLICSR: Health Wellness and Cancer Survivorship Centre

Toronto, Ontario, M5G 2N2, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

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 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.

Primary outcomes

  1. Accrual Rate

    Time frame: Throughout study completion, up to 24 weeks.

    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.

  2. Retention Rates

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

    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.

  3. Adherence

    Time frame: Through study completion, up to 24 weeks.

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

  4. Intervention Safety

    Time frame: Through study completion, up to 24 weeks.

    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.

Secondary outcomes

  1. Pain Intensity

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

    Measured using the numeric pain rating scale (NPRS). Scored on a 1-10 scale, 1 being no pain and 10 being worst pain imaginable.

  2. CIPN Symptoms

    Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 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.

  3. CIPN-related Disability

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

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

  4. Strength (Upper Body)

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

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

  5. Strength (Lower Body)

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

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

  6. Balance

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

    Measured using the Short Physical Performance Battery (SPPB) Balance Test. The SPPB balance test provides a score from 0 to 4 with lower scores meaning worse outcomes.

  7. Gait Speed

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

    Measured using the Four-Metre Gait Speed Test.

  8. Aerobic Functional Capacity

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

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Cancer Research Society

Registry information

Official study title

EX-CIPN: An Exercise-based Rehabilitation Intervention to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Acronym: EX-CIPN

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 8, 2024
Registry last updated
Jun 4, 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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