Daily hand-held vibration therapy for neuropathy relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention designed to alleviate the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients' hands. The researchers hypothesize that this therapy will not only reduce CIPN symptoms but also enhance the quality of life for affected individuals. By gathering early data on the intervention's feasibility and efficacy, the study seeks to lay the groundwork for future clinical trials exploring vibration therapy as a treatment option for CIPN.

Why it matters

Who can join: the full rules

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

Where it's running

• Indiana University Health West
  Avon, Indiana, United States Recruiting
• Indiana University Melvin & Bren Simon Cancer Center
  Indianapolis, Indiana, United States Recruiting
• IU Health Joe & Shelly Schwarz Cancer Center
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Erin Newton, MD — Indiana University
• Study coordinator: Cheri West, RN
• Email: chawest@iu.edu
• Phone: 317-278-3021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.