Daily Hand-Held Vibration Therapy

Last updated: April 23, 2025
Sponsor: Indiana University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neuropathy

Cancer

Neurologic Disorders

Treatment

Vibration therapy

Clinical Study ID

NCT04207437
IUSCC-0677
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years or older at enrollment

  2. Able to provide informed consent and Health Insurance Portability and AccountabilityAct (HIPAA) authorization

  3. Have completed chemotherapy ≥ 60 days prior to enrollment

  4. Were exposed to neurotoxic chemotherapy with one or more of the following agents inthe following doses: Paclitaxel (cumulative dose: ≥ 300 mg/m2) Docetaxel (cumulativedose: ≥ 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)

  5. Continue to display evidence of sensory CIPN in the hands rated at a Grade ≥ 2according the National Cancer Institute's Common Toxicity Criteria-Adverse Events (NCI-CTC-AE, Version 5.0) Scale ≥ 60 days post-chemotherapy

  6. If solid tumor cancer, must have non-metastatic cancer

  7. Agree to return to clinic for required study related measurements at specifiedintervals

Exclusion

Exclusion Criteria:

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

  2. Known diagnosis of diabetes mellitus.

  3. Known contraindications for vibration therapy to hands, including deep venousthrombosis of the upper extremity or ongoing skin infection.

  4. Will be receiving concurrent radiation of the upper-extremity

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Vibration therapy
Phase:
Study Start date:
December 06, 2021
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Indiana University Health West

    Avon, Indiana 46123
    United States

    Active - Recruiting

  • IU Health Joe & Shelly Schwarz Cancer Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Indiana University Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.