Exercise for Peripheral Neuropathy

(CIPN Trial)

Recruiting at 103 trial locations

Overseen By Dee Murray, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester NCORP Research Base

Disqualifiers: Physical limitations, Active exercisers, Planned surgery, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

133 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercise can more effectively treat chemotherapy-induced peripheral neuropathy (CIPN) than usual drug treatments. CIPN occurs when chemotherapy damages nerves, causing symptoms like tingling and numbness. Participants will either follow a home-based exercise program (the Exercise Intervention) or continue with usual care for six weeks. Individuals who have had cancer, received certain chemotherapy drugs in the last nine months, and experience significant CIPN symptoms may qualify for the trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options beyond standard care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, especially since the trial focuses on exercise as a treatment.

What prior data suggests that this exercise intervention is safe for treating chemotherapy-induced peripheral neuropathy?

Research has shown that exercise is generally safe for managing neuropathy symptoms. Some studies found that exercise can slow neuropathy progression by 20% in people with diabetes. This suggests exercise might also help with nerve problems caused by chemotherapy.

Exercise programs, including activities like walking and lifting weights, have improved symptoms and nerve function. This is encouraging because exercise is not only well-tolerated but also beneficial. Importantly, these studies did not report any serious side effects from exercise, making it a safer option compared to many medications.

Exercise is usually considered low-risk and is already recommended for many health conditions. Therefore, participating in a trial using exercise to help with neuropathy might be a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise intervention for peripheral neuropathy because it offers a unique approach focusing on physical activity rather than medication. Unlike standard treatments, which often involve pain relievers or anti-seizure medications, this program involves a home-based, self-directed walking and resistance exercise regimen tailored to each participant. The goal is to improve nerve function and reduce symptoms through natural means, which could provide a non-invasive alternative with fewer side effects. Additionally, incorporating tactile sensitivity tests and optional MRIs allows for detailed monitoring of changes, potentially revealing new insights into how exercise impacts nerve health.

What evidence suggests that exercise might be an effective treatment for chemotherapy-induced peripheral neuropathy?

Research has shown that exercise can significantly alleviate symptoms of chemotherapy-induced peripheral neuropathy (CIPN). One study found that patients who exercised experienced less severe CIPN symptoms than those who did not. Another review found that exercise, particularly strength and aerobic training, effectively reduces symptoms and improves muscle and joint function in individuals with peripheral neuropathy. In this trial, participants in Arm 1 will undergo an exercise intervention, which includes a home-based, self-directed, individually tailored progressive walking and resistance program. Participants in Arm 2 will receive usual care. Additionally, exercise has been shown to increase pain tolerance, making it easier to manage pain associated with neuropathy. These findings suggest that exercise can be a beneficial treatment option for reducing CIPN symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Ian R Kleckner

Principal Investigator

University of Rochester NCORP Research Base

Are You a Good Fit for This Trial?

This trial is for adults with cancer who have nerve damage from chemotherapy, can understand English, and are expected to live at least six more months. They should be able to do some exercise and not have other health issues that make exercising unsafe. People who've had recent surgery or radiation (except hormone/biologic therapy) or already exercise regularly can't join.

Inclusion Criteria

Be able to provide written informed consent

I am currently receiving or have recently completed chemotherapy that can affect my nerves.

Be able to read and understand English

Exclusion Criteria

I am not planning any surgery or radiation during the study, but hormone or biological treatments are okay.

My doctor says I can't do certain exercises because of my health issues.

You are currently in an active or maintenance stage of regular exercise, as indicated on the screening form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week home-based individually tailored progressive exercise intervention or standard care

6 weeks

1 initial visit with exercise instructor, 2 booster meetings

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention

Trial Overview The study is looking at whether exercise helps people with nerve damage caused by chemotherapy better than the usual drug treatments. Participants will follow a home-based walking and resistance training program designed to see if it reduces their symptoms of neuropathy.

How Is the Trial Designed?

Group I: Arm 1 (EXCAP, tactile sensitivity test, counseling) Experimental Treatment 5 Interventions

Participants undergo the EXCAP intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, participants meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5. Participants may optionally undergo MRI on study.

Group II: Arm 2 (usual care, tactile sensitivity test) Active Control 6 Interventions

Participants receive usual care for 6 weeks. At the end of the study, participants may receive the exercise kit and complete the EXCAP program as in Arm 1. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. Participants may optionally undergo MRI on study.

Who Is Running the Clinical Trial?

University of Rochester NCORP Research Base

Lead Sponsor

Trials

14

Recruited

9,100+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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 study involving 87 patients with diabetic peripheral neuropathy (DPN) found that moderate intensity aerobic exercise significantly improved nerve conduction velocity and reduced neuropathy symptoms after eight weeks compared to standard care.

The results suggest that incorporating moderate aerobic exercise into treatment plans for individuals with type 2 diabetes can help slow the progression of DPN, highlighting its potential as an effective intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise on peripheral nerve functions of population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, parallel group randomized controlled trial. Dixit, S., Maiya, AG., Shastry, BA.[2022]

In a study of patients with idiopathic distal, symmetrical, axonal polyneuropathy, regular exercise was linked to a lower likelihood of experiencing painful neuropathy, suggesting that even low-intensity exercise can be beneficial.

While exercise did not significantly impact other symptoms like numbness, weakness, or balance issues, it indicates that maintaining an active lifestyle may help reduce pain in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of exercise and pain in patients with idiopathic distal axonal polyneuropathies. Stewart, S., Thomas, S., Van Doormaal, PT., et al.[2021]

An 8-week program of moderate intensity aerobic exercise significantly improved various aspects of quality of life for individuals with type 2 diabetes and peripheral neuropathy, including pain, sensory symptoms, and daily living activities.

The study involved 77 participants, with significant improvements noted in overall quality of life and specific quality of life impacts, indicating that aerobic exercise is an effective intervention for managing neuropathy symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise on quality of life in population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, randomized controlled trial. Dixit, S., Maiya, A., Shastry, B.[2022]

A 12-week program of exercises for peripheral neuropathy (EPN) significantly reduced inflammatory markers TNF-α and CRP, and improved balance, pain, and tingling in women with diabetic neuropathy, compared to a control group.

Both EPN and low-intensity resistance training led to significant decreases in fasting blood glucose and HbA1c levels, indicating improved metabolic control in diabetic patients, while numbness showed no significant change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effect of two therapeutic exercises on the inflammatory and physiological conditions and complications of diabetic neuropathy in female patients. Nadi, M., Bambaeichi, E., Marandi, SM.[2022]

In a study of 100 patients with Type 2 diabetic peripheral neuropathy, those who engaged in resistance exercise for 6 months showed significant improvements in their neurological symptoms, as indicated by reduced Toronto clinical scoring system (TCSS) scores compared to the control group.

Resistance exercise also led to significant reductions in fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1C) levels, suggesting that this form of exercise can effectively help manage blood sugar levels in patients with Type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of resistance exercise on peripheral neuropathy in Type 2 diabetes mellitus. Yang, X., Liu, L., Yang, L., et al.[2020]

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]

A 16-week resistance exercise training program significantly improved the speed of ankle and knee strength generation during stair ascent and descent in individuals with diabetes, particularly those with diabetic peripheral neuropathy, suggesting enhanced stability and reduced fall risk.

The study involved 43 participants, and while muscle activation patterns changed, the primary factor for improved strength generation was the increase in muscle strength from the resistance training, highlighting the importance of such exercises in safety programs for people with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance exercise training increases lower limb speed of strength generation during stair ascent and descent in people with diabetic peripheral neuropathy. Handsaker, JC., Brown, SJ., Bowling, FL., et al.[2016]

Citations

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