Exercise Rehabilitation for Peripheral Neuropathy

(EX-CIPN Trial)

Overseen By Eric Antonen

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University Health Network, Toronto

Must not be taking: Ado-trastuzumab emtansine

Disqualifiers: Neurological conditions, Pre-existing neuropathy, others

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

Compensation: Varies

Number of Visits: 8

Duration: 10 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific exercise program (EX-CIPN) can alleviate lingering nerve pain and numbness after chemotherapy, known as peripheral neuropathy. Researchers seek to assess the safety, feasibility, and participant satisfaction with the exercise plan. The trial includes a 10-week exercise routine, health coaching, and activity tracking with a FitBit. It targets cancer survivors who have experienced nerve issues due to treatment, are at least six months post-chemotherapy, and currently engage in less than 90 minutes of exercise weekly. Participants must be able to walk independently and have access to videoconferencing tools.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking ado-trastuzumab emtansine (TDM1).

What prior data suggests that the EX-CIPN exercise-based intervention is safe for participants with chemotherapy-induced peripheral neuropathy?

Research has shown that exercise programs like the EX-CIPN have been manageable for participants in past studies. In one study, participants in a similar exercise program experienced fewer symptoms of peripheral neuropathy, which causes tingling, pain, or numbness due to nerve damage. This suggests that exercise can safely and effectively manage these symptoms.

As this study is in an early phase, it primarily assesses whether the exercise program is safe and feasible for home use. Early phase trials typically involve fewer participants, allowing for close monitoring of any side effects. So far, similar studies have not reported major safety concerns, which is encouraging for potential participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EX-CIPN because it offers a novel approach to managing peripheral neuropathy through exercise-based rehabilitation. Unlike standard treatments, which often include medication or physical therapy, EX-CIPN provides a personalized exercise program combined with remote monitoring and person-to-person clinical support. This innovative combination not only empowers patients to take an active role in their treatment but also allows for continuous oversight and adjustments tailored to individual needs, potentially enhancing both effectiveness and convenience.

What evidence suggests that this exercise-based intervention is effective for treating CIPN?

Research has shown that exercise can greatly reduce the symptoms of chemotherapy-induced peripheral neuropathy (CIPN). One study found that participants who followed an exercise program experienced much milder symptoms than those who did not exercise. In this trial, participants will receive the EX-CIPN program, a 10-week exercise plan designed for home use, making it easy to fit into daily routines. This program is safe and practical, offering hope to those dealing with the ongoing effects of CIPN. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for cancer survivors who are dealing with persistent chemotherapy-induced peripheral neuropathy (CIPN). Participants should be willing to engage in a 10-week exercise program, receive health coaching calls, and wear a FitBit. Specific eligibility criteria were not provided.

Inclusion Criteria

Currently engaging in < 90min per week of planned moderate-intensity aerobic exercise

I finished chemotherapy more than 6 months ago.

I have nerve damage from chemotherapy.

Exclusion Criteria

Currently enrolled in other cancer rehabilitation or exercise-based programs/interventions

I am currently on Kadcyla (TDM1) treatment.

I had nerve damage before starting chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 10-week remote, individualized exercise program with health coaching calls and Fitbit monitoring

10 weeks

5 health coaching calls (weeks 2, 3, 4, 6, and 8)

Follow-up

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

14 weeks

3 assessment visits (baseline, post-intervention, 3-months post-intervention)

What Are the Treatments Tested in This Trial?

Interventions

• EX-CIPN

Trial Overview The EX-CIPN intervention being tested involves an individualized exercise program designed to treat symptoms of CIPN. The study will assess the safety, acceptability, and feasibility of this approach through participant assessments at various stages.

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Scrambler therapy (ST) significantly reduced pain levels in adolescents with chemotherapy-induced peripheral neuropathy (CIPN), with pain scores dropping from an average of 9.22 to 0.11 after treatment, indicating strong efficacy.

The therapy also improved quality of life across multiple areas, including general activity, mood, walking ability, sleep, and social relationships, with no reported side effects, suggesting it is a safe and effective option for managing CIPN in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scrambler therapy efficacy and safety for neuropathic pain correlated with chemotherapy-induced peripheral neuropathy in adolescents: A preliminary study. Tomasello, C., Pinto, RM., Mennini, C., et al.[2019]

A 12-week tai chi program led to long-term engagement in exercise for older adults with peripheral neuropathy, with participants continuing classes for an additional 18 months, highlighting the importance of psychosocial support in maintaining exercise routines.

Participants showed significant improvements in strength, balance, and stamina, confirming the physical benefits of tai chi, although changes in quality of life scores were not statistically significant, qualitative feedback indicated meaningful improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Tai Chi on Peripheral Neuropathy Revisited: A Mixed-Methods Study. Hermanns, M., Haas, BK., Rath, L., et al.[2020]

A 3-week specific exercise regimen significantly improved balance measures in 10 subjects with diabetic peripheral neuropathy, compared to a control group, indicating its potential efficacy for enhancing postural stability.

While the intervention also showed a trend towards improved confidence in balance (measured by the ABC scale), further research is needed to see if these improvements lead to a reduced risk of falls in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A focused exercise regimen improves clinical measures of balance in patients with peripheral neuropathy. Richardson, JK., Sandman, D., Vela, S.[2022]

Exercise significantly reduces the severity of chemotherapy-induced peripheral neuropathy (CIPN) symptoms and improves peripheral deep sensitivity, based on a meta-analysis of 13 studies.

Sensoriomotor training and mind-body exercises are particularly effective in alleviating CIPN symptoms, while active nerve-specific and mind-body exercises enhance peripheral deep sensitivity in cancer patients and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions to reduce chemotherapy-induced peripheral neuropathy severity: A meta-analysis. Nuñez de Arenas-Arroyo, S., Cavero-Redondo, I., Torres-Costoso, A., et al.[2023]

In a study involving 131 patients with chemotherapy-induced polyneuropathy (CIPN), whole-body vibration (WBV) combined with an integrated program (IP) showed a significant reduction in the time needed for the chair-rising test, indicating improved physical fitness and coordination compared to standard treatment alone.

All patients reported less pain and symptoms over time, with both treatment groups showing improvement, but WBV specifically enhanced warm-detection-threshold, suggesting it may have additional benefits for sensory function in CIPN patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises. Schönsteiner, SS., Bauder Mißbach, H., Benner, A., et al.[2020]

Exercise therapy may provide short-term benefits in reducing neuropathic symptoms and improving physical function in people with diabetic neuropathy, based on a review of 11 randomized clinical trials involving 517 participants.

However, the overall quality of evidence supporting these benefits is very low, and no significant effects were observed on psychosocial aspects of health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise therapy on diabetic neuropathy: A systematic review and meta-analysis. Hernando-Garijo, I., Medrano-de-la-Fuente, R., Mingo-Gómez, MT., et al.[2023]

A 12-week integrated exercise program significantly improved glycemic control and peripheral sensation in patients with Type 2 diabetic peripheral neuropathy, as indicated by better results in various measures like HbA1c and sensory tests.

The exercise program included techniques like massage and foam rolling to enhance blood circulation and reduce pain, which likely facilitated the patients' ability to engage in aerobic and resistance exercises more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Exercise and Glycemic and Peripheral Sensation Control in Diabetic Neuropathy: A Single-Blind, Randomized Controlled Trial. Heidari, M., Zolaktaf, V., Ghasemi, G., et al.[2022]

The review found inadequate evidence to determine the overall effect of exercise therapy on functional ability in people with peripheral neuropathy, as only one trial fully met the inclusion criteria and results could not be pooled due to variability.

However, there is some indication that progressive resisted exercise may moderately improve muscle strength in the affected muscles of individuals with peripheral neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for people with peripheral neuropathy. White, CM., Pritchard, J., Turner-Stokes, L.[2022]

The study involved 10 adults with diabetic peripheral neuropathy (DPN) who participated in a 4-week intervention aimed at promoting physical activity self-management, which included exercise tasters and behavior change counseling.

Participants experienced significant reductions in foot symptoms, specifically aching and burning pain, after the intervention, with no major adverse events reported, indicating that the Physical Activity Intelligence (PAI) self-monitoring approach is both safe and potentially effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal Activity Intelligence eHealth intervention in people with diabetic peripheral neuropathy: A feasibility study. Coombes, BK., Bisset, LM., Sierra-Silvestre, E., et al.[2023]

An 8-week multimodal exercise intervention significantly improved symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in 29 cancer survivors, enhancing balance, mobility, and quality of life without affecting neurophysiologic parameters.

The study suggests that exercise can be a beneficial rehabilitation strategy for CIPN, warranting further large-scale trials to confirm these findings and explore the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based rehabilitation for cancer survivors with chemotherapy-induced peripheral neuropathy. McCrary, JM., Goldstein, D., Sandler, CX., et al.[2021]

This pilot study will assess the effectiveness of home-based high-tone external muscle stimulation (HTEMS) therapy in improving symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in 50 patients over 8 weeks, using a randomized controlled design.

The primary outcome will be measured using the EORTC QLQ-CIPN 20 questionnaire, with secondary outcomes including changes in health-related quality of life and various sensory and strength assessments, aiming to identify a potentially novel treatment for CIPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of high tone therapy and transcutaneous electrical nerve stimulation therapy in chemotherapy-induced polyneuropathy. Schaffler-Schaden, D., Sassmann, R., Johansson, T., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12040081/

A remotely delivered exercise-based rehabilitation ... Acute CIPN develops during treatment and generally improves over the first 3–6 months following treatment completion [9,10]; however, in 30–40% ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06405542

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 ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0322371

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.

4. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-025-01223-1

Home-based exercise for chemotherapy-induced peripheral ... This study aimed to evaluate the feasibility and safety of a 12-week hybrid intervention, combining outpatient supervision with home-based self-exercise in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352578922000078

Beneficial effects of exercise on chemotherapy-induced ... Following the intervention, patients in the exercise group were found to have significantly less severe peripheral neuropathy symptoms compared to the control ...