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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-site interventional open label pilot study of a non-significant risk medical device on patients with defined peripheral neuropathy secondary to chemotherapy (N=10). Patients who have received chemotherapy and have evidence of neuropathy will be seen at MD Anderson. Their severity of neuropathy will be documented and assessed by physical therapy, occupational therapy and based on self-reported activities of daily living (ADL) impairment.

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 data supports the effectiveness of the treatment Vibrating Device, Vibrating Insoles, Muscle Vibration Device, Wearable Focal Muscle Vibration Therapy for chemotherapy-induced neuropathy?

Research suggests that whole-body vibration (WBV) training can help reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN), such as pain and balance issues. Studies have shown improvements in sensory and motor symptoms, making WBV a promising treatment option for CIPN. ^{1 2 3 4 5}

Is muscle vibration therapy safe for humans?

Research on vibrating insoles and similar devices for conditions like diabetic neuropathy suggests they are generally safe for use in humans, as no adverse effects were reported in the studies. ^{3 6 7 8 9}

How does the vibrating device treatment differ from other treatments 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, and mobility in patients with neuropathy. Unlike other treatments, it offers a non-drug approach that directly targets muscles to potentially enhance sensation and reduce symptoms. ^{3 4 7 10 11}

Research Team

David McCall, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

References

1. Germany 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. [2022]

2. England 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. [2018]

3. England 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. [2023]

4. Switzerland 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The role of knee immobilizers in cancer patients with femoral neuropathy. [2019]

6. United States 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of vibrating insoles on standing balance in diabetic neuropathy. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

The effects of Vibro-medical insole on vibrotactile sensation in diabetic patients with mild-to-moderate peripheral neuropathy. [2018]

9. South Africa pubmed.ncbi.nlm.nih.gov

Improving vibration perception in a patient with type 2 diabetes and sensory peripheral neuropathy. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Focal Muscle Vibration on Pain, Balance, Mobility, and Sensation in Individuals with Diabetic Peripheral Neuropathy: A Pilot Study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Design and evaluation of a portable smart-phone based peripheral neuropathy test platform. [2020]