Virtual Exercise Program for Peripheral Neuropathy
(EX-CIPN 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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment with assessments at 3-months and 6-months post-intervention
Open-label extension (optional)
Participants in the usual care group are offered the EX-CIPN program after completing all study assessments
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
This arm is provided with an intervention that includes an individualized exercise program, remote monitoring, and remote person-to-person clinical support.
This arm is provided usual oncology care and is provided the intervention after completing all study assessments (5-6 months)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
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.
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