Virtual Exercise Program for Peripheral Neuropathy

(EX-CIPN Trial)

Overseen By Eric Antonen, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University Health Network, Toronto

Disqualifiers: Neurological conditions, Pre-existing neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

Inclusion Criteria

I have numbness or tingling that is at least mild in severity.

Are able to communicate sufficiently in English to complete intervention, questionnaires, and consent

Have access to and able to operate videoconferencing

Exclusion Criteria

Have neuropathy that pre-existed chemotherapy receipt (i.e. diabetic neuropathy)

Currently enrolled in other rehabilitation or exercise-based interventions

Currently meeting all recommendations from the physical activity guidelines for cancer survivors

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the EX-CIPN group complete a 10-week remote, individualized exercise program with health coaching calls and wear a FitBit to track physical activity

10 weeks

5 health coaching calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 3-months and 6-months post-intervention

24 weeks

2 assessments (virtual)

Open-label extension (optional)

Participants in the usual care group are offered the EX-CIPN program after completing all study assessments

5-6 months

What Are the Treatments Tested in This Trial?

Interventions

• EX-CIPN

How Is the Trial Designed?

Group I: EX-CIPN Exercise-based Intervention Experimental Treatment 1 Intervention

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

Group II: Usual Care Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+