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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

Must not have

Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.)

Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have nerve pain in my hands not caused by chemotherapy.

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I don't have blood clots or skin infections in my arms that prevent vibration therapy.

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I have been diagnosed with diabetes.

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I will be getting radiation therapy on my arm or shoulder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

1,039 Previous Clinical Trials

1,219,042 Total Patients Enrolled

Indiana Clinical and Translational Sciences InstituteOTHER

19 Previous Clinical Trials

4,407 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.