Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)
NCT ID: NCT06405542
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2024-04-25
2025-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy
NCT04888988
Chemotherapy Induced Peripheral Neuropathy (CIPN)
NCT03272919
Cycling-Based Aerobic Exercise Intervention for Individuals With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
NCT07150117
The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy
NCT06962579
Exercise and Nutrition Interventions During Chemotherapy
NCT03021174
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Health Network, Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ELLICSR: Health Wellness and Cancer Survivorship Centre
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-5839
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.