日常手持振动疗法
每日手持振动疗法治疗化疗引起的周围神经病变 (CIPN)：一项初步研究
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Lacy Slayton
- 电话号码：(317) 278-6718
- 邮箱：lslayton@iu.edu
研究联系人备份
- 姓名：Cheri West, RN
- 电话号码：317-278-3021
- 邮箱：chawest@iu.edu
学习地点
-
-
Indiana
-
Avon、Indiana、美国、46123
- 招聘中
- Indiana University Health West
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接触：
- Cheri West
- 电话号码：317-278-3021
- 邮箱：chawestr@iu.edu
-
Indianapolis、Indiana、美国、46202
- 招聘中
- Indiana University Melvin & Bren Simon Cancer Center
-
接触：
- Cheri West
- 电话号码：317-278-3021
- 邮箱：chawest@iu.edu
-
Indianapolis、Indiana、美国、46202
- 招聘中
- IU Health Joe & Shelly Schwarz Cancer Center
-
接触：
- Cheri West
- 电话号码：317-278-3021
- 邮箱：chawest@iu.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Vibration Therapy
Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks. |
vibration therapy using hand held vibration device |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
招募可行性-筛选后同意参与研究的患者百分比
大体时间：招募期（研究开始后最多5年）
|
招募期（研究开始后最多5年）
|
|
|
Feasibility of compliance- percentage of vibration therapy sessions completed
大体时间：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. |
4 weeks
|
|
Acceptability of Intervention- percentage of patients who answer agree on acceptability form
大体时间：4 weeks
|
percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form |
4 weeks
|
|
Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores
大体时间：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 |
baseline, week 1, week 2, week 3, week 4
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in CIPN Severity via the CIPN20 questionnaire scores
大体时间：baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8
|
Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum) |
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
大体时间：baseline, week 4, week 8
|
Descriptive statistics (frequency and percentage for each category, mean and standard deviation of scores assigned to each category (range: 0-7)) will be used to describe the CIPN-related QOL participants have on each of the three categories related to quality of life |
baseline, week 4, week 8
|
合作者和调查者
调查人员
- 首席研究员：Erin Newton, MD、Indiana University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.