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Daily Hand-Held Vibration Therapy

RecruitingNAAges 18 Years - anyAllIndiana University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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: โ‰ฅ 300 mg/m2) Docetaxel (cumulative dose: โ‰ฅ 100 mg/m2) Nab-paclitaxel (cumulative dose: โ‰ฅ 750 mg/m2) Oxaliplatin (cumulative dose: โ‰ฅ 510 mg/m2) Carboplatin (cumulative dose: โ‰ฅ 600 mg/m2) Cisplatin (cumulative dose: โ‰ฅ 200 mg/m2) Vincristine (cumulative dose: โ‰ฅ 4 mg/m2) Bortezomib (cumulative dose: โ‰ฅ 16 mg/m) 5. Continue to display evidence of sensory CIPN in the hands rated at a Grade โ‰ฅ 2 according the National Cancer Institute's Common Toxicity Criteria-Adverse Events (NCI-CTC-AE, Version 5.0) Scale โ‰ฅ 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
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What it tests

  • Vibration therapy
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Where

3 sites
Indiana University Health West
Avon, United States
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, United States
IU Health Joe & Shelly Schwarz Cancer Center
Indianapolis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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