Recruiting

Vibration Therapy

Sponsor:

Indiana University

Code:

NCT04207437

Conditions

Neuropathy

Cancer

Chemotherapeutic Drug - Induced Nephropathy

Chemotherapeutic Toxicity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vibration therapy

Study Details

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

Study ID

NCT04207437

Start date

Dec 6, 2021

Status verified date

May, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years or older at enrollment
2. Able to provide informed consent and Health Insurance Portability and Accountability Act (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 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)
5. 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
6. If solid tumor cancer, must have non-metastatic cancer
7. Agree to return to clinic for required study related measurements at specified intervals

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 venous thrombosis of the upper extremity or ongoing skin infection.
4. Will be receiving concurrent radiation of the upper-extremity

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Vibration Therapy

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

Interventions

Vibration therapy

vibration therapy using hand held vibration device

Primary outcome measure

  • Feasibility of recruitment- percentage of patients who agree to participate in the study after screening [ Time Frame: recruitment period (up to 5 year after study starts) ]
  • Feasibility of compliance- percentage of vibration therapy sessions completed [ Time Frame: 4 weeks ]
  • Acceptability of Intervention- percentage of patients who answer agree on acceptability form [ Time Frame: 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 [ Time Frame: baseline, week 1, week 2, week 3, week 4 ]

Central Contacts and Locations

Central contacts

Locations

Indiana University Health West

Recruiting

Avon, Indiana, United States, 46123

Contacts

Indiana University Melvin & Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

IU Health Joe & Shelly Schwarz Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

More Information

Sponsor

Indiana University

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • Neuropathy
  • Vibration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-28.