Nausea, Vomiting
Conditions
Brief summary
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.
Interventions
DEVICEActivated 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.
DEVICEUnactivated Nometex Device
Sponsors
Neurowave Medical Technologies
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Women with ovarian (including fallopian tube) or advanced endometrial or cervical cancer 2. Chemotherapy-naïve or who have had previous chemotherapy exposure, but who have not yet received the first infusion 3. 18 years of age or older, and can provide cognizant informed consent presenting to the Helen F. Graham Cancer Center 4. ECOG Status of 0-2 5. Standardized Antiemetic Regimen
Exclusion criteria
1. Pre-existing or at-risk for a peripheral neuropathy in region of device placement 2. Implanted cardiac pace maker 3. Nickel or other metal allergies 4. Previous experience with median nerve/P6 stimulation 5. Receiving concurrent radiation therapy 6. Previous participants of this study will be excluded from future participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of episodes of Vomiting | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delayed severe nausea | 5 days | The delayed number severe nausea episodes on days 2-5. |
| Acute Emetic Episodes | 1 day | More specifically, the number of episodes of vomiting on Day 1. |
| Rescue Medication Use | 1 month | Will look at the use of rescue medication throughout treatment. |
| Delayed emetic episodes | 5 days | Looking at the number of delayed emetic episodes during days 2-5 of treatment. |
| Severity of nausea | 1 day | The severity of acute nausea on day 1 of treatment. |
Countries
United States
Outcome results
None listed