Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy
Study Details
Study Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Device: 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.
|
| Sham Comparator: Unactivated Nometex Device The Nometex device will not be activated and therefore have no effect on the nausea/vomiting associated with chemotherapy. |
Device: Unactivated Nometex Device
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Acute Emetic Episodes [1 day]
More specifically, the number of episodes of vomiting on Day 1.
- Severity of nausea [1 day]
The severity of acute nausea on day 1 of treatment.
- Delayed severe nausea [5 days]
The delayed number severe nausea episodes on days 2-5.
- Delayed emetic episodes [5 days]
Looking at the number of delayed emetic episodes during days 2-5 of treatment.
- Rescue Medication Use [1 month]
Will look at the use of rescue medication throughout treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women with ovarian (including fallopian tube) or advanced endometrial or cervical cancer
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Chemotherapy-naïve or who have had previous chemotherapy exposure, but who have not yet received the first infusion
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18 years of age or older, and can provide cognizant informed consent presenting to the Helen F. Graham Cancer Center
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ECOG Status of 0-2
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Standardized Antiemetic Regimen
Exclusion Criteria:
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Pre-existing or at-risk for a peripheral neuropathy in region of device placement
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Implanted cardiac pace maker
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Nickel or other metal allergies
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Previous experience with median nerve/P6 stimulation
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Receiving concurrent radiation therapy
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Previous participants of this study will be excluded from future participation in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helen F. Graham Cancer Center | Newark | Delaware | United States | 19713 |
Sponsors and Collaborators
- Christiana Care Health Services
- Neurowave Medical Technologies
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- Treish I, Shord S, Valgus J, Harvey D, Nagy J, Stegal J, Lindley C. Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy. Support Care Cancer. 2003 Aug;11(8):516-21. Epub 2003 Jun 27.
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- NMT-Nometex