Daily Hand-Held Vibration Therapy

Launched by INDIANA UNIVERSITY · Dec 19, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called daily hand-held vibration therapy to help reduce nerve damage in the hands caused by certain cancer treatments, known as chemotherapy-induced peripheral neuropathy (CIPN). The study aims to see if using a small device that provides gentle vibrations for just 3 minutes a day can make a difference in how people feel and improve their quality of life after chemotherapy. Researchers are gathering early information to determine if this approach is safe and feasible, which could lead to more in-depth studies in the future.

To be eligible for this study, participants need to be at least 18 years old, have completed chemotherapy at least 60 days before joining, and still show symptoms of CIPN in their hands. However, individuals with pre-existing nerve issues in their hands, diabetes, or certain other health conditions won't be able to participate. If chosen to take part in this study, participants will attend the clinic for regular check-ups and assessments to monitor their progress and the effects of the vibration therapy. This trial is currently recruiting participants and welcomes individuals of all genders.

Gender

ALL

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