Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Device: Activated Nometex Device
* Device: Unactivated Nometex Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Activated Nometex Device<br>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. | Device: Activated Nometex Device<br>* 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.<br>|
| Sham Comparator: Unactivated Nometex Device<br>The Nometex device will not be activated and therefore have no effect on the nausea/vomiting associated with chemotherapy. | Device: Unactivated Nometex Device<br> <br> * Other names: Patients using this device will be given an unactivated Nometex device. It should be the same in appearance as the activated device.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of Vomiting | 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. | 1 month | 
| Severity of Nausea | One of the primary outcomes we are investigating is the severity of nausea in patients with active wrist bands verse the sham wrist bands. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Emetic Episodes | More specifically, the number of episodes of vomiting on Day 1. | 1 day | 
| Severity of nausea | The severity of acute nausea on day 1 of treatment. | 1 day | 
| Delayed severe nausea | The delayed number severe nausea episodes on days 2-5. | 5 days | 
| Delayed emetic episodes | Looking at the number of delayed emetic episodes during days 2-5 of treatment. | 5 days | 
| Rescue Medication Use | Will look at the use of rescue medication throughout treatment. | 1 month |