Muscle Vibration for Chemotherapy-Induced Neuropathy

Overseen By David McCall

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Amputations, Prosthetics, Hypotension, Pregnant, Blind, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vibrating device designed to assist individuals with nerve damage and walking difficulties resulting from chemotherapy. Participants will use the device attached to various parts of their leg to determine if it alleviates symptoms. The trial is suitable for individuals aged 6 to 39 who have had cancer and experience walking difficulties due to chemotherapy-induced nerve damage. Participants must be able to walk, even with the aid of a walker or similar support. As an unphased trial, this study provides participants the chance to contribute to innovative research that may enhance mobility for those affected by chemotherapy-induced nerve damage.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that this vibrating device is safe for patients with chemotherapy-induced neuropathy?

Research has shown that using a vibrating device for nerve pain caused by chemotherapy is generally safe. Other studies have used this type of device without causing major problems for participants. The vibrating device is considered low-risk and is not expected to harm users.

In similar research, people using vibrating devices reported less pain and improved balance and movement. These studies noted no major adverse side effects, suggesting that the treatment is well-tolerated.

This device is not a drug, so it doesn't have the same side effects as medication. It is designed to ease symptoms by applying gentle vibrations to the leg, which most people handle well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chemotherapy-induced neuropathy focus on managing symptoms with medications like pain relievers or antidepressants. However, the vibrating device offers a novel approach by using targeted vibrations to potentially alleviate nerve pain. Researchers are excited about this method because it doesn't rely on medication and might reduce side effects associated with drugs. This device could also offer a non-invasive and simple way to provide relief, which is a promising shift from traditional pharmacological treatments.

What evidence suggests that this vibrating device is effective for chemotherapy-induced neuropathy?

Research shows that muscle vibration therapy might help people with nerve damage from chemotherapy. In this trial, participants will use a vibrating device. One study found that a wearable device for muscle vibration significantly improved pain, movement, and sensation in people with nerve damage from diabetes. Although this isn't the same condition, it suggests the treatment might also work for nerve issues related to chemotherapy. Another study found that similar vibration treatments improved walking in people with nerve damage. This device could potentially enhance balance and reduce pain. These findings highlight the device's promise in treating symptoms of nerve damage. ^{1 2 3 4 6}

Who Is on the Research Team?

David McCall, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for people aged 6-39 with peripheral neuropathy from chemotherapy, who can walk (with support like a walker if needed) and follow the study's procedures. They must understand the study and give consent. It's not for those with lower limb amputations, severe deformities, unstable blood pressure, other risky conditions, or pregnant women.

Inclusion Criteria

I have had cancer before.

I have walking difficulties due to nerve damage, as diagnosed by my doctor.

I have had cancer before.

Exclusion Criteria

I do not have low blood pressure (below 90/60 mmHg) and am stable.

The investigator thinks there are reasons why you cannot participate in the study, but they are not specified.

I have a condition or use a device that affects how I walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a vibrating device on selected muscles while walking to assess its effect on gait control

1 week

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and self-reported outcomes after device application

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vibrating Device

Trial Overview

The study tests a vibrating device on patients at MD Anderson who have gait issues due to nerve damage from cancer treatment. The goal is to see how this non-significant risk device affects their walking ability and daily activities.

How Is the Trial Designed?

Group I: Vibrating Device Experimental Treatment 1 Intervention

you will be asked to walk up and down a hallway 5 times with the vibrating device strapped to different parts of your leg.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

The Vibro-medical insole significantly improved pressure sensation in diabetic patients with mild-to-moderate peripheral neuropathy, particularly at key areas of the foot, after a 30-minute walk (p < 0.001).

Vibration sensation also showed improvement at the big toe using a 256 Hz tuning fork (p < 0.05), indicating that the insole can help enhance sensory perception in daily activities for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Vibro-medical insole on vibrotactile sensation in diabetic patients with mild-to-moderate peripheral neuropathy. Bagherzadeh Cham, M., Mohseni-Bandpei, MA., Bahramizadeh, M., et al.[2018]

A study involving 20 diabetic patients with mild-to-moderate peripheral neuropathy found that using a total-contact insole significantly improved balance control compared to regular shoes.

The addition of vibration to the insole further enhanced balance control, especially in conditions where patients had their eyes closed, indicating that vibratory feedback may be beneficial for stability in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibro-medical insoles with and without vibrations on balance control in diabetic patients with mild-to-moderate peripheral neuropathy. Bagherzadeh Cham, M., Mohseni-Bandpei, MA., Bahramizadeh, M., et al.[2021]

In a study involving 32 participants (17 with diabetic neuropathy and 15 nondisabled), vibrating insoles improved standing balance in individuals with neuropathy, but only when they were distracted by an attention-demanding task.

No balance improvement was observed in nondisabled subjects, suggesting that the vibrating insoles may specifically benefit those with balance issues related to neuropathy, highlighting the need for further development to enhance their effectiveness in daily use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibrating insoles on standing balance in diabetic neuropathy. Hijmans, JM., Geertzen, JH., Zijlstra, W., et al.[2022]

A therapeutic vibrating insole used for 20 minutes a day over 35 days significantly improved vibration perception in a 63-year-old male patient with type 2 diabetes and sensory peripheral neuropathy, with effects lasting up to 10 months.

Improved vibration perception may help reduce the risk of foot ulcers and lower limb amputations in diabetic patients, highlighting the potential clinical benefits of using vibrating insoles for those with sensory peripheral neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving vibration perception in a patient with type 2 diabetes and sensory peripheral neuropathy. Ennion, L., Hijmans, J.[2022]

A randomized controlled trial is investigating the effects of whole-body vibration (WBV) training on chemotherapy-induced peripheral neuropathy (CIPN) symptoms in 44 patients, aiming to assess improvements in sensory and motor functions over a 12-week period.

The primary goal is to measure patient-reported reductions in CIPN-related symptoms, with secondary outcomes including nerve conduction studies and quality of life, potentially providing new insights into supportive care for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individually tailored whole-body vibration training to reduce symptoms of chemotherapy-induced peripheral neuropathy: study protocol of a randomised controlled trial-VANISH. Streckmann, F., Hess, V., Bloch, W., et al.[2023]

A randomized controlled trial with 40 participants showed that both sensorimotor training (SMT) and whole-body vibration training (WBV) significantly improved symptoms of chemotherapy-induced peripheral neuropathy (CIPN), including tendon reflexes and pain levels.

SMT demonstrated superior results in improving tendon reflexes and subjective symptom reports, while WBV was more effective in reducing pain, indicating that both exercise interventions are safe and feasible options for managing CIPN symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensorimotor training and whole-body vibration training have the potential to reduce motor and sensory symptoms of chemotherapy-induced peripheral neuropathy-a randomized controlled pilot trial. Streckmann, F., Lehmann, HC., Balke, M., et al.[2022]

Chemotherapy-induced peripheral neuropathy (CIPN) affects about 50% of patients undergoing treatment for various cancers, leading to significant disability and reduced quality of life, as well as potential treatment delays or discontinuation.

A multicenter clinical trial involving 236 cancer patients is investigating whether sensorimotor training (SMT) or whole body vibration (WBV) can prevent or reduce the symptoms of CIPN, with the hypothesis that these interventions may improve patients' quality of life and reduce the need for dose adjustments in chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The preventive effect of sensorimotor- and vibration exercises on the onset of Oxaliplatin- or vinca-alkaloid induced peripheral neuropathies - STOP. Streckmann, F., Balke, M., Lehmann, HC., et al.[2018]

Whole-body vibration (WBV) therapy shows mixed results in improving strength, balance, and pain in patients with peripheral neuropathies, with only two out of five studies reporting beneficial effects on neuropathic pain.

The overall quality of the studies reviewed was low, indicating a need for more rigorous research to determine the effectiveness of WBV as a rehabilitation strategy for patients suffering from chemotherapy-induced peripheral neuropathy (CIPN).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Body Vibration as a Modality for the Rehabilitation of Peripheral Neuropathies: Implications for Cancer Survivors Suffering from Chemotherapy-Induced Peripheral Neuropathy. Verhulst, AL., Savelberg, HH., Vreugdenhil, G., et al.[2020]

In a study of five cancer patients with femoral neuropathy, the use of knee immobilizers significantly reduced the number of falls by up to 10-fold, demonstrating their effectiveness in enhancing safety during rehabilitation.

Patients also reported increased ambulatory distance (between 105 and 420 feet), improved feelings of stability, and higher overall activity levels while using the knee immobilizer, indicating its positive impact on mobility and confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of knee immobilizers in cancer patients with femoral neuropathy. Jones, VA., Stubblefield, MD.[2019]

A 4-week study involving 23 participants with diabetic peripheral neuropathy showed that wearable focal muscle vibration (FMV) therapy significantly reduced pain levels and improved mobility, with participants reporting high satisfaction and compliance.

While balance and sensation improvements were noted, they were not statistically significant; however, there was a trend suggesting that better balance may correlate with reduced pain levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Focal Muscle Vibration on Pain, Balance, Mobility, and Sensation in Individuals with Diabetic Peripheral Neuropathy: A Pilot Study. Chandrashekhar, R., Wang, H., Dionne, C., et al.[2021]

The PeriVib is a novel portable test platform that effectively measures vibratory sensation thresholds in patients with peripheral neuropathy, showing a strong correlation with the established Biothesiometer device.

In a study of 28 subjects with chemotherapy-induced peripheral neuropathy, the PeriVib demonstrated its ability to provide quick and reliable assessments, taking only about 5 minutes to complete, making it suitable for both clinical and home use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and evaluation of a portable smart-phone based peripheral neuropathy test platform. Jacobs, PG., Hanaway, P., Leitschuh, J., et al.[2020]

Citations

1.

withpower.com

withpower.com/trial/phase-9-2021-22dcd

Muscle Vibration for Chemotherapy-Induced Neuropathy

The vibrating device treatment is unique because it uses wearable focal muscle vibration therapy, which can be applied at home and may improve pain, balance ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04959929

Wearable Focal Vibration for Chemotherapy-Induced ...

This is an initial Phase I single-site, single-arm, double-baseline repeated measures feasibility study of wearable focal vibration (FV with Myovolt) for ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12537586/

Effects on chemotherapy-induced peripheral neuropathy by ...

This study aimed to evaluate the effects of a 12-week programme, including moderate strength training with and without whole-body vibration ...

4.

withpower.com

withpower.com/trial/phase-peripheral-nervous-system-diseases-7-2021-2137e

Wearable Focal Vibration for Peripheral Neuropathy

A study on wearable focal muscle vibration therapy showed significant improvements in pain, mobility, and sensation for people with diabetic peripheral ...

5.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-09935

Muscle Vibration for the Treatment of Peripheral ...

This pilot trial evaluates whether a vibrating device can improve walking ability (gait) in patients who have peripheral neuropathy-associated gait ...

6.

researchgate.net

researchgate.net/publication/349745856_Wearable_Focal_Muscle_Vibration_on_Pain_Balance_Mobility_and_Sensation_in_Individuals_with_Diabetic_Peripheral_Neuropathy_A_Pilot_Study

(PDF) Wearable Focal Muscle Vibration on Pain, Balance ...

This study explores the benefits of 4-week, in-home wearable focal muscle vibration (FMV) therapy on pain, balance, mobility, and sensation in people with DPN.