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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Recruitment Status : Withdrawn (Did not receive IRB approval from our institution therefore the study was closed.)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

Tracking Information
First Submitted Date  ICMJE October 14, 2013
First Posted Date  ICMJE November 8, 2013
Last Update Posted Date October 2, 2015
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01980160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
  • Acute Emetic Episodes [ Time Frame: 1 day ]
    More specifically, the number of episodes of vomiting on Day 1.
  • Severity of nausea [ Time Frame: 1 day ]
    The severity of acute nausea on day 1 of treatment.
  • Delayed severe nausea [ Time Frame: 5 days ]
    The delayed number severe nausea episodes on days 2-5.
  • Delayed emetic episodes [ Time Frame: 5 days ]
    Looking at the number of delayed emetic episodes during days 2-5 of treatment.
  • Rescue Medication Use [ Time Frame: 1 month ]
    Will look at the use of rescue medication throughout treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Nausea
  • Vomiting
Intervention  ICMJE
  • 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
    Other Name: Patients using this device will be given an unactivated Nometex device. It should be the same in appearance as the activated device.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Activated Nometex Device
  • Sham Comparator: Unactivated Nometex Device
    The Nometex device will not be activated and therefore have no effect on the nausea/vomiting associated with chemotherapy.
    Intervention: Device: Unactivated Nometex Device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 10, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2013)
102
Estimated Study Completion Date  ICMJE January 2016
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01980160
Other Study ID Numbers  ICMJE NMT-Nometex
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christiana Care Health Services
Study Sponsor  ICMJE Christiana Care Health Services
Collaborators  ICMJE Neurowave Medical Technologies
Investigators  ICMJE Not Provided
PRS Account Christiana Care Health Services
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP