Chemotherapy-induced Peripheral Neuropathy (CIPN)
Conditions
Keywords
cancer rehabilitation, peripheral neuropathy, randomized controlled trial
Brief summary
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
BEHAVIORALEX-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 have scheduled remote check-ins and health coaching sessions with their assigned RKin on weeks 2, 3, 4, 6, and 8 of the intervention. During these calls, the RKin will progress the exercise program as needed, discuss and develop goals, and identify potential barriers and solutions in achieving their goals. After the 10-week intervention participants will receive a 3-month maintenance phase with 2 monthly remote check-ins.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
A pragmatic, parallel group, two-arm, single-blind, randomized controlled trial (pRCT)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIPN Symptoms | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) | Measured using the European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy (EORTC CIPN-20) questionnaire. Results are scored on a scale between 20-80 with higher scores meaning worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CIPN-related disability | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) | Measured using the Rasch-built Overall Disability Scale for patients with chemotherapy-induced peripheral neuropathy CIPN-R-ODS. Results are scored on a scale between 0-56 with lower scores meaning worse outcomes. |
| Strength (Upper Body) | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) | Measured via handgrip dynamometry or grip strength test (GST). |
| Strength (Lower Body) | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) | Measured by a 30-second sit to stand test (30-s STS). |
| Balance | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) | Measured using the 7-Item Berg Balance Test. The test provides a score from 0 to 28 with lower scores meaning worse outcomes. |
| Gait Speed | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) | Measured using the Four-Metre Gait Speed Test. |
| Aerobic Functional Capacity | Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks) | Measured using a 6-minute walk test (6MWT). |
Countries
Canada
Contacts
CONTACTEric Antonen, MSc
Outcome results
None listed