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

NCT01980160 | Withdrawn

• 1 other identifier: NMT-Nometex
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting

Outcome Measures

Primary Outcomes (2)

• Number of episodes of Vomiting

  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

  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 Outcomes (5)

• Acute Emetic Episodes

  1 day

• Severity of nausea

  1 day

• Delayed severe nausea

  5 days

• Delayed emetic episodes

  5 days

• Rescue Medication Use

  1 month

Study Arms (2)

Activated Nometex Device

ACTIVE COMPARATOR

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

Unactivated Nometex Device

SHAM COMPARATOR

The Nometex device will not be activated and therefore have no effect on the nausea/vomiting associated with chemotherapy.

Device: Unactivated Nometex Device

Interventions

Activated Nometex Device 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.

Activated Nometex Device

Unactivated Nometex Device DEVICE

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

Unactivated Nometex Device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with ovarian (including fallopian tube) or advanced endometrial or cervical cancer
• Chemotherapy-naïve or who have had previous chemotherapy exposure, but who have not yet received the first infusion
• years of age or older, and can provide cognizant informed consent presenting to the Helen F. Graham Cancer Center
• ECOG Status of 0-2
• Standardized Antiemetic Regimen

You may not qualify if:

• Pre-existing or at-risk for a peripheral neuropathy in region of device placement
• Implanted cardiac pace maker
• Nickel or other metal allergies
• Previous experience with median nerve/P6 stimulation
• Receiving concurrent radiation therapy
• Previous participants of this study will be excluded from future participation in this study.

Sponsors & Collaborators

• Christiana Care Health Services: lead
• Neurowave Medical Technologies: collaborator

Study Sites (1)

Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Related Publications (16)

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MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: November 8, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

US (1)