Daily Hand-Held Vibration Therapy

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Daily Hand-Held Vibration Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study

Daily Hand-Held Vibration Therapy

Condition
Neuropathy
Intervention / Treatment

-

Contacts and Locations

Avon

Indiana University Health West, Avon, Indiana, United States, 46123

Indianapolis

Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, United States, 46202

Indianapolis

IU Health Joe & Shelly Schwarz Cancer Center, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Erin Newton, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

2025-07