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
- 1
- 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.
研究组 & 干预措施
Activated Nometex Device
Nometex Device that is activated so will be sending electrical pulses to the median nerve which will travel through afferent nerve fibers to the emetic centers of the brain. It is in these areas that the neurotransmitters modulate signals going to the stomach via the Vagus nerve. These electrical signals normalize the stomach rhythms, thereby alleviating nausea and vomiting.
干预措施: Activated Nometex Device (Device)
Unactivated Nometex Device
The Nometex device will not be activated and therefore have no effect on the nausea/vomiting associated with chemotherapy.
干预措施: Unactivated Nometex Device (Device)
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)