Daily Hand-Held Vibration Therapy

NCT04207437 | Recruiting DMC FDA Device

• 1 other identifier: IUSCC-0677
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

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

Neuropathy; Cancer; Chemotherapeutic Drug - Induced Nephropathy; Chemotherapeutic Toxicity

Keywords

Neuropathy; Vibration

Outcome Measures

Primary Outcomes (4)

• Feasibility of recruitment- percentage of patients who agree to participate in the study after screening

  recruitment period (up to 5 year after study starts)

• Feasibility of compliance- percentage of vibration therapy sessions completed

  Compliance with the daily vibration therapy sessions will be evaluated using data from a Daily Compliance Form Researchers will calculate the percentage of sessions that were completed calculated for each participant, on each hand. Participant compliance with the intervention will be considered acceptable if participants complete ≥ 80% of the sessions they were assigned.

  4 weeks

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

  percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form

  4 weeks

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

  CIPN 20 questionnaire scores will be compared to baseline weekly to identify an increase of 30% during the intervention period. The CIPN scores range from 20 to 80 with 80 being consistent with the most severe neuropathy symptoms

  baseline, week 1, week 2, week 3, week 4

Secondary Outcomes (2)

• Change in CIPN Severity via the CIPN20 questionnaire scores

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

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

  baseline, week 4, week 8

Study Arms (1)

Vibration Therapy

EXPERIMENTAL

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

Device: Vibration therapy

Interventions

Vibration therapy DEVICE

vibration therapy using hand held vibration device

Vibration Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older at enrollment
• Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
• Have completed chemotherapy ≥ 60 days prior to enrollment
• Were exposed to neurotoxic chemotherapy with one or more of the following agents in the following doses: Paclitaxel (cumulative dose: ≥ 300 mg/m2) Docetaxel (cumulative dose: ≥ 100 mg/m2) Nab-paclitaxel (cumulative dose: ≥ 750 mg/m2) Oxaliplatin (cumulative dose: ≥ 510 mg/m2) Carboplatin (cumulative dose: ≥ 600 mg/m2) Cisplatin (cumulative dose: ≥ 200 mg/m2) Vincristine (cumulative dose: ≥ 4 mg/m2) Bortezomib (cumulative dose: ≥ 16 mg/m)
• Continue to display evidence of sensory CIPN in the hands rated at a Grade ≥ 2 according the National Cancer Institute's Common Toxicity Criteria-Adverse Events (NCI-CTC-AE, Version 5.0) Scale ≥ 60 days post-chemotherapy
• If solid tumor cancer, must have non-metastatic cancer
• Agree to return to clinic for required study related measurements at specified intervals

You may not qualify if:

• Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.)
• Known diagnosis of diabetes mellitus.
• Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection.
• Will be receiving concurrent radiation of the upper-extremity

Sponsors & Collaborators

• Indiana University: lead
• Indiana Clinical and Translational Sciences Institute: collaborator

Study Sites (3)

Indiana University Health West

Avon, Indiana, 46123, United States

RECRUITING

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

IU Health Joe & Shelly Schwarz Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Erin Newton, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ceri West

CONTACT

317-278-3021; chawest@iu.edu

Lacy Slayton

CONTACT

(317) 278-6718; lslayton@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Model Details: Subjects will be instructed to perform 3-minutes of vibration therapy per hand each day using a hand held vibration device for 4 weeks. The amount of time that subjects perform vibration therapy will be recorded on their Daily Compliance form and subjects will complete questionnaires daily and weekly.

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 20, 2019
• Study Start: December 6, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)