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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • EX-CIPN

Treatment groups

240 Participants
are divided into 2 treatment groups