Daily Hand-Held Vibration Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Feasibility of compliance- percentage of vibration therapy sessions completed
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.)
- •Known diagnosis of diabetes mellitus.
- •Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection.
- •Will be receiving concurrent radiation of the upper-extremity
研究组 & 干预措施
Vibration Therapy
Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks.
干预措施: Vibration therapy (Device)
结局指标
主要结局
Feasibility of compliance- percentage of vibration therapy sessions completed
时间窗: 4 weeks
Compliance with the daily vibration therapy sessions will be evaluated using data from a Daily Compliance Form Researchers will calculate the percentage of sessions that were completed calculated for each participant, on each hand. Participant compliance with the intervention will be considered acceptable if participants complete ≥ 80% of the sessions they were assigned.
Acceptability of Intervention- percentage of patients who answer agree on acceptability form
时间窗: 4 weeks
percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form
Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores
时间窗: baseline, week 1, week 2, week 3, week 4
CIPN 20 questionnaire scores will be compared to baseline weekly to identify an increase of 30% during the intervention period. The CIPN scores range from 20 to 80 with 80 being consistent with the most severe neuropathy symptoms
Feasibility of recruitment- percentage of patients who agree to participate in the study after screening
时间窗: recruitment period (up to 5 year after study starts)
次要结局
- Change in CIPN Severity via the CIPN20 questionnaire scores(baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8)
- Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale(baseline, week 4, week 8)
研究者
Erin Newton, MD
Assistant Professor of Clinical Medicine
Indiana University