Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04207437

Daily Hand-Held Vibration Therapy

Led by Indiana University · Updated on 2026-02-06

16

Participants Needed

3

Research Sites

242 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

I

Indiana Clinical and Translational Sciences Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life. The hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating CIPN in the future.

CONDITIONS

Official Title

Daily Hand-Held Vibration Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older at enrollment
  • Able to provide informed consent and HIPAA authorization
  • Completed chemotherapy at least 60 days before enrollment
  • Exposure to neurotoxic chemotherapy with specified agents and doses: Paclitaxel (≥ 300 mg/m2), Docetaxel (≥ 100 mg/m2), Nab-paclitaxel (≥ 750 mg/m2), Oxaliplatin (≥ 510 mg/m2), Carboplatin (≥ 600 mg/m2), Cisplatin (≥ 200 mg/m2), Vincristine (≥ 4 mg/m2), Bortezomib (≥ 16 mg/m)
  • Ongoing sensory CIPN in hands rated Grade ≥ 2 by NCI-CTC-AE Version 5.0 at least 60 days post-chemotherapy
  • If solid tumor cancer, must be non-metastatic
  • Agree to return to clinic for required study-related measurements
Not Eligible

You will not qualify if you...

  • Pre-existing neuropathy affecting hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression)
  • Known diagnosis of diabetes mellitus
  • Contraindications for hand vibration therapy, including deep venous thrombosis of upper extremity or ongoing skin infection
  • Receiving concurrent radiation therapy to the upper extremity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Indiana University Health West

Avon, Indiana, United States, 46123

Actively Recruiting

2

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

3

IU Health Joe & Shelly Schwarz Cancer Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

C

Ceri West

CONTACT

L

Lacy Slayton

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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