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

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

NCT ID: NCT06405542

Condition: Chemotherapy-induced Peripheral Neuropathy

Conditions: Official terms:
Peripheral Nervous System Diseases

Conditions: Keywords:
Cancer Rehabilitation
Peripheral Neuropathy

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: EX-CIPN
Description: 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.
Arm group label: EX-CIPN Exercise- Based intervention

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

Criteria for eligibility:
Criteria:
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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: ELLICSR: Health Wellness and Cancer Survivorship Centre

Address:
City: Toronto
Zip: M5G 2N2
Country: Canada

Status: Recruiting

Contact:
Last name: Eric Antonen

Phone: 416-581-8453
Email: eric.antonen2@uhn.ca

Start date: April 25, 2024

Completion date: July 1, 2025

Lead sponsor:
Agency: University Health Network, Toronto
Agency class: Other

Source: University Health Network, Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06405542