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

Not Applicable

Withdrawn

• Conditions: Nausea; Vomiting
• Interventions: Device: Activated Nometex Device; Device: Unactivated Nometex Device

• Registration Number: NCT01980160
• Lead Sponsor: Christiana Care Health Services

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-14
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-02
• Primary Completion: 2015-11
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activated Nometex 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.
Unactivated Nometex Device	Unactivated Nometex Device	The Nometex device will not be activated and therefore have no effect on the nausea/vomiting associated with chemotherapy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rescue Medication Use	1 month	Will look at the use of rescue medication throughout treatment.
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.

Trial Locations

Locations (1)

Helen F. Graham Cancer Center; 🇺🇸 Newark, Delaware, United States