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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 years or older at enrollment
✓. Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
✓. Have completed chemotherapy ≥ 60 days prior to enrollment
✓. 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)
✓. 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
✓. If solid tumor cancer, must have non-metastatic cancer
✓. Agree to return to clinic for required study related measurements at specified intervals
Exclusion criteria
What they're measuring
1
Feasibility of recruitment- percentage of patients who agree to participate in the study after screening
Timeframe: recruitment period (up to 5 year after study starts)
2
Feasibility of compliance- percentage of vibration therapy sessions completed
Timeframe: 4 weeks
3
Acceptability of Intervention- percentage of patients who answer agree on acceptability form
Timeframe: 4 weeks
4
Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores