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

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ClinicalTrials.gov Identifier: NCT01980160
Recruitment Status : Withdrawn (Did not receive IRB approval from our institution therefore the study was closed.)
First Posted : November 8, 2013
Last Update Posted : October 2, 2015
Sponsor:
Collaborator:
Neurowave Medical Technologies
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Nausea Vomiting Device: Activated Nometex Device Device: Unactivated Nometex Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : November 2013
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Patients using this device will be given an unactivated Nometex device. It should be the same in appearance as the activated device.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Acute Emetic Episodes [ Time Frame: 1 day ]
    More specifically, the number of episodes of vomiting on Day 1.

  2. Severity of nausea [ Time Frame: 1 day ]
    The severity of acute nausea on day 1 of treatment.

  3. Delayed severe nausea [ Time Frame: 5 days ]
    The delayed number severe nausea episodes on days 2-5.

  4. Delayed emetic episodes [ Time Frame: 5 days ]
    Looking at the number of delayed emetic episodes during days 2-5 of treatment.

  5. Rescue Medication Use [ Time Frame: 1 month ]
    Will look at the use of rescue medication throughout treatment.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980160


Locations
United States, Delaware
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
Sponsors and Collaborators
Christiana Care Health Services
Neurowave Medical Technologies

Publications:

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01980160     History of Changes
Other Study ID Numbers: NMT-Nometex
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Emetics
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents