Daily hand-held vibration therapy for neuropathy relief

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

This study is testing if a daily 3-minute hand-held vibration therapy can help people with chemotherapy-induced nerve pain in their hands feel better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Avon, Indiana and 2 other locations)
• Trial ID: NCT04207437 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have completed chemotherapy at least 60 days prior and exhibit moderate to severe sensory CIPN in their hands.

Not a fit: Patients currently undergoing chemotherapy or those with metastatic cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve the quality of life for patients suffering from chemotherapy-induced neuropathy.

How similar studies have performed: While this approach is novel, similar studies exploring vibration therapy for neuropathy have shown promising results.

Eligibility criteria

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 this trial is running

Avon, Indiana and 2 other locations

• 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: Ceri West

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