NCT01980160

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Christiana Care Health Services · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nausea
• Vomiting

Interventions

Type	Name	Description
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.
DEVICE	Unactivated Nometex Device

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2013-11-08
• Last updated: 2015-10-02

Locations

1 site across 1 country: United States