240 Participants NeededMy employer runs this trial

Virtual Exercise Program for Peripheral Neuropathy

(EX-CIPN Trial)

EA
Overseen ByEric Antonen, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University Health Network, Toronto
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a virtual exercise program, called EX-CIPN, can reduce symptoms like numbness and tingling in cancer survivors who have completed chemotherapy. Participants will either follow this exercise program or continue with their usual care, and researchers will compare their progress. The study seeks individuals who have completed chemotherapy, experience neuropathic pain, and can walk and use video calls. If successful, this program could ease daily activities for those dealing with lingering side effects from cancer treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual exercise program is safe for individuals with peripheral neuropathy?

Research has shown that exercise programs like EX-CIPN are generally safe for people with nerve problems caused by chemotherapy, known as CIPN. One study found that both exercise and physical therapy effectively managed CIPN symptoms without major side effects. Participants handled the programs well. Another study found that exercises, including activities for the heart, strength, and balance, offer a low-risk way to reduce CIPN symptoms.

Overall, evidence suggests that the EX-CIPN program is a safe choice for those wanting to lessen CIPN symptoms.12345

Why are researchers excited about this trial?

Researchers are excited about the EX-CIPN exercise-based intervention for peripheral neuropathy because it offers a unique approach compared to current treatments, which typically include medications like gabapentin or duloxetine for symptom relief. Unlike these standard drug therapies, EX-CIPN incorporates a personalized virtual exercise program that is remotely monitored and supported by healthcare professionals. This innovative approach not only aims to improve physical function but also provides ongoing clinical support and engagement, which could enhance patient adherence and overall outcomes. By focusing on exercise and remote care, this treatment has the potential to address the condition in a more holistic and accessible manner.

What evidence suggests that the EX-CIPN program is effective for improving CIPN symptoms?

Research has shown that exercise might alleviate symptoms of chemotherapy-induced peripheral neuropathy (CIPN), which involves nerve pain and numbness following cancer treatment. Some studies have found that individuals who exercised experienced less severe symptoms than those who did not. For example, an aerobic exercise program reduced CIPN symptoms in ovarian cancer patients. However, other studies did not find significant improvement, indicating the need for further research. In this trial, participants in the EX-CIPN Exercise-based Intervention arm will receive an individualized exercise program with remote monitoring and clinical support. Overall, despite mixed results, exercise appears to be a low-risk option that might help manage CIPN symptoms.678910

Are You a Good Fit for This Trial?

This trial is for cancer survivors who have ongoing numbness, tingling, or pain in their hands or feet after finishing chemotherapy at least 6 months ago. Participants must be able to walk (with or without help), use videoconferencing, and communicate in English. People with neuropathy from other causes or certain neurological conditions can't join.

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
See 5 more

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
See 1 more

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

Trial Overview

The study compares a 10-week virtual exercise program called EX-CIPN plus health coaching against usual care for people with persistent nerve symptoms after chemo. Some will get the exercise program right away; others will get it later. Activity is tracked using a FitBit.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: EX-CIPN Exercise-based InterventionExperimental Treatment1 Intervention
Group II: Usual Care ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

a systematic review and network meta-analysis - PMC

Exercise interventions may be beneficial for improving QOL and CIPN symptoms. High-quality large clinical trials and data are needed to conclude that exercise ...

Exercise intervention for the management of chemotherapy ...

This systematic review and network meta-analysis (NMA) aimed to evaluate the comparative effects of exercise on CIPN.

Effect of Exercise on Chemotherapy-Induced Peripheral ...

However, a meta-analysis of the 4 trials with CIPN as a composite outcome found no significant improvement associated with exercise. To date, no ...

Effects of Physical Exercise on Chemotherapy-Induced ...

The findings of this study have clinical, educational, and research implications that are crucial for managing chemotherapy-induced peripheral neuropathy (CIPN) ...

Protocol for a phase I feasibility trial | PLOS One

The EX-CIPN program is a 10-week virtual home-based intervention that includes an individualized exercise program supported with a mobile application.

A remotely delivered exercise-based rehabilitation program ...

The EX-CIPN study uses an exercise-based approach with behaviour change strategies to target physical activity and behaviour change to support ...

Effectiveness of Exercise and Physiotherapy in Chemotherapy ...

Both exercise and physiotherapy interventions were effective, safe, and feasible for the management of chemotherapy-induced peripheral ...

NCT06405542 | Exercise-based Rehabilitation to Treat ...

The goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent ...

EX-CIPN: A Phase I Trial of a Remote Exercise-based ...

The EX-CIPN intervention is a remote, 10-week exercise-based intervention. It includes an individualized progressive exercise program, remote monitoring, and ...

Exercise and Physical Medicine Interventions for Managing ...

Chemotherapy-induced peripheral neuropathy (CIPN) is a frustrating and distressing complication of many chemotherapy drugs.