Randomized Single-Blind Study of Nometex as an Adjunct to Standard Anti-emetics in Ovarian and Advanced Endometrial and Cervical Cancer Patients Who Receive Moderately to Highly Emetogenic Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of episodes of Vomiting
研究概览
简要总结
The primary study hypotheses are that, without increasing doses of breakthrough medications or device intolerance, the Nometex™ device worn for 5-days beginning with the day of chemotherapy administration in women with ovarian or advanced endometrial or cervical cancer will, as an adjunct to standard-of-care anti-emetics, reduce vomiting episodes, and reduce the severity of nausea.
The secondary hypotheses are that the Nometex™ device reduces acute (Day 1) emetic episodes, day 1 and days 2-5 severity of nausea, and delayed (days 2-5) emetic episodes without increasing doses of breakthrough medications or device intolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with ovarian (including fallopian tube) or advanced endometrial or cervical cancer
- •Chemotherapy-naïve or who have had previous chemotherapy exposure, but who have not yet received the first infusion
- •18 years of age or older, and can provide cognizant informed consent presenting to the Helen F. Graham Cancer Center
- •ECOG Status of 0-2
- •Standardized Antiemetic Regimen
排除标准
- •Pre-existing or at-risk for a peripheral neuropathy in region of device placement
- •Implanted cardiac pace maker
- •Nickel or other metal allergies
- •Previous experience with median nerve/P6 stimulation
- •Receiving concurrent radiation therapy
- •Previous participants of this study will be excluded from future participation in this study.
结局指标
主要结局
Number of episodes of Vomiting
时间窗: 1 month
The primary outcome measure we are looking for is the number of vomiting episodes in patients with active wrist bands verse the sham wrist bands.
Severity of Nausea
时间窗: 1 month
One of the primary outcomes we are investigating is the severity of nausea in patients with active wrist bands verse the sham wrist bands.
次要结局
- Rescue Medication Use(1 month)
- Acute Emetic Episodes(1 day)
- Severity of nausea(1 day)
- Delayed severe nausea(5 days)
- Delayed emetic episodes(5 days)