Clinical trial · Interventional
Trial of a Virtual Exercise-based Rehabilitation Program to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN)
A Pragmatic Randomized Controlled Trial of a Virtual Exercise-based Rehabilitation Intervention for Persistent Chemotherapy-Induced Peripheral Neuropathy (EX-CIPN).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Peripheral Neuropathy (CIPN) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EX-CIPN | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EX-CIPN Exercise-based Intervention
- description
- This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support.
- interventionNames
- Behavioral: EX-CIPN
- type
- NO_INTERVENTION
- label
- Usual Care Control
- description
- This arm is provided usual oncology care and is provided the intervention after completing all study assessments (5-6 months)
Primary outcomes (1)
- measure
- CIPN Symptoms
- timeFrame
- Baseline, post-intervention (10 weeks), 3-months post-intervention (22 weeks), 6-months post-intervention (34 weeks)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available