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

September 30, 2015 updated by: Christiana Care Health Services

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F. Graham Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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:
  • 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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of episodes of Vomiting
Time Frame: 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.
1 month
Severity of Nausea
Time Frame: 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.
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christiana Care Health Services

Collaborators

Neurowave Medical Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

November 1, 2015

Study Completion (ANTICIPATED)

January 1, 2016

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (ESTIMATE)

November 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMT-Nometex

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nausea

Clinical Trials on Activated Nometex Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe