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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
ELLICSR: Health Wellness and Cancer Survivorship Centre
RECRUITING
Toronto
Contact Information
Primary
Eric Antonen
eric.antonen2@uhn.ca
416-581-8453
Time Frame
Start Date: 2024-04-25
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov