Trial of a Virtual Exercise-based Rehabilitation Program to Treat Persistent Chemotherapy-Induced Peripheral Neuropathy (CIPN) (EX-CIPN)

University Health Network, Toronto

Status and phase: Not yet enrolling; Phase 3

Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)

Treatments: Behavioral: EX-CIPN

Study type: Interventional

Funder types: Other

Identifiers

NCT07481149

25-5957

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

EX-CIPN Exercise-based Intervention

Experimental group

Description:

This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support.

Treatment:

Behavioral: EX-CIPN

Usual Care Control

No Intervention group

Description:

This arm is provided usual oncology care and is provided the intervention after completing all study assessments (5-6 months)