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Vibration Therapy for Peripheral Neuropathy

N/A

Recruiting

Led By Erin Newton, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If solid tumor cancer, must have non-metastatic cancer

Were exposed to neurotoxic chemotherapy with specified cumulative doses of certain agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up recruitment period (up to 1 year after study starts)

Awards & highlights

Study Summary

This trial is testing if a 3-minute daily hand-held vibration therapy can reduce the severity of Chemotherapy-Induced Peripheral Neuropathy (CIPN) in the hands and improve quality of life.

Who is the study for?

This trial is for adults who finished chemotherapy at least 60 days ago, have ongoing hand neuropathy from the treatment, and can consent to participate. They must not have metastatic cancer or other causes of neuropathy like diabetes or carpal tunnel syndrome. Participants agree to regular clinic visits.Check my eligibility

What is being tested?

The study tests a daily 3-minute vibration therapy on hands to see if it's safe and can lessen nerve pain caused by chemotherapy (CIPN). The goal is also to check if this improves life quality related to CIPN, setting the stage for future trials.See study design

What are the potential side effects?

While specific side effects are not detailed in the provided information, common concerns with vibration therapy may include temporary discomfort or tingling in treated areas. Safety regarding more serious side effects will be evaluated during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My solid tumor cancer has not spread to other parts of my body.

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I have been treated with high doses of chemotherapy that can affect the nerves.

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I am 18 years old or older.

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I have had hand numbness or pain for over 60 days after chemotherapy.

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I finished my chemotherapy more than 60 days ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ recruitment period (up to 1 year after study starts)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~recruitment period (up to 1 year after study starts)

This trial's timeline: 3 weeks for screening, Varies for treatment, and recruitment period (up to 1 year after study starts) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of Intervention- percentage of patients who answer agree on acceptability form

Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores

Feasibility of compliance- percentage of vibration therapy sessions completed

+1 more

Secondary outcome measures

Change in CIPN Severity via the CIPN20 questionnaire scores

Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vibration TherapyExperimental Treatment1 Intervention

Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vibration therapy

2011

N/A

~50

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,966 Total Patients Enrolled

Indiana Clinical and Translational Sciences InstituteOTHER

19 Previous Clinical Trials

4,657 Total Patients Enrolled

Erin Newton, MD4.796 ReviewsPrincipal Investigator - Indiana University

Medical School - Aga Khan University Medical College, Bachelor of Medicine, Bachelor of Surgery

West Virginia University (Residency)

1 Previous Clinical Trials

5Patient Review

The office staff were lovely and I didn't have to wait long before seeing the doctor. Dr. Sher was so helpful and answered all my questions thoroughly.

Media Library

Hand-Held Vibration Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04207437 — N/A

Cancer Research Study Groups: Vibration Therapy

Cancer Clinical Trial 2023: Hand-Held Vibration Therapy Highlights & Side Effects. Trial Name: NCT04207437 — N/A

Hand-Held Vibration Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04207437 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being enrolled in this medical trial?

"Affirmative, the clinicaltrial.gov database confirms that this medical trial is actively seeking participants. The study was initially published on February 12th 2020 and most recently edited June 15th 2022; it requires 16 patients from two sites for full participation."

Answered by AI

Are there any openings remaining in this clinical experiment?

"Affirmative. Clinicaltrials.gov has information supporting that this medical trial is actively seeking participants; it was initially posted on December 2nd 2020 and most recently updated June 15th 2022. 16 patients must be recruited from two sites for the study to proceed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Daily Hand-Held Vibration Therapy

Erin Newton, MD 2021. "Daily Hand-Held Vibration Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04207437.

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