EX-CIPN: An Exercise-based Rehabilitation Intervention to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Retention Rates
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: EX-CIPN (Behavioral)
Outcomes
Primary Outcomes
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.
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.
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
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
- CIPN Symptoms(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))
- Gait Speed(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))
- Aerobic Functional Capacity(Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks))
- Pain Intensity(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))
- Balance(Baseline, post-intervention (10 weeks), 3-months post-intervention (20-24 weeks))