Trial of a Virtual Exercise-based Rehabilitation Program to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EX-CIPN.
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pragmatic Randomized Controlled Trial of a Virtual Exercise-based Rehabilitation Intervention for Persistent Chemotherapy-Induced Peripheral Neuropathy (EX-CIPN).
Overview
The purpose of this study is to determine the effectiveness of the EX-CIPN program in reducing the strength of CIPN symptoms and CIPN-related disability and improving the ability to complete everyday activities. This will be done by determining whether it is better to receive the EX-CIPN program or better to receive no additional intervention. To do this, some of the participants in this study will get EX-CIPN and others will receive usual care. Those who receive usual care will be offered EX-CIPN upon study completion. The main question it aims to answer is: • Is EX-CIPN effective in improving CIPN symptoms for cancer survivors experiencing persistent CIPN? Participants in both study groups will be asked to: • Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention Participants in the EX-CIPN group will be asked to: * Complete an additional aassessment at 6-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
Interventions
- Behavioral 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 specific to CIPN symptoms. Remote Monitoring: Fitbit™ devices will be used to monitor patients' physical activity over the duration of the program. Fitness trackers can promote behaviour change. Remote Person-to-Person Clinical Support: Participants will
Primary outcome measures
- CIPN Symptoms [Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
Secondary outcome measures (6)
- CIPN-related disability [Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
- Strength (Upper Body) [Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
- Strength (Lower Body) [Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
- Balance [Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
- Gait Speed [Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
- Aerobic Functional Capacity [Time frame: Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)]
Eligibility criteria
Inclusion criteria
- diagnosed with any type of cancer
- received chemotherapy treatment as part of curative-intent therapy (no minimum dose)
- >6 months following chemotherapy completion with no current plans for further chemotherapy
- report Grade 1 or higher on the numbness and tingling severity item of the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
- neuropathic pain 3 or higher on the Neuropathic Pain 4 (DN4) (interview)
- capable of ambulation and transfers (with or without gait/transfer aid) (ECOG score 0-2)
- are able to communicate sufficiently in English to complete intervention, questionnaires, and consent
- have access to and able to operate videoconferencing
Exclusion criteria
- currently meeting all recommendations from the physical activity guidelines for cancer survivors
- have any neurological conditions influencing cognition (i.e. dementia, Alzheimer's) and preventing safe or appropriate engagement with exercise recommendation
- have neuropathy that pre-existed chemotherapy receipt (i.e. diabetic neuropathy)
- currently enrolled in other rehabilitation or exercise-based interventions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- ELLICSR: Health Wellness and Cancer Survivorship Centre — Toronto
Identifiers
NCT: NCT07481149 · 25-5957