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

N/AWithdrawnNCT01980160

Christiana Care Health Services

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Conditions

Nausea Vomiting

Interventions

Activated Nometex DeviceDEVICE

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 DeviceDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Helen F. Graham Cancer Center

Newark, Delaware, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 month

Secondary Outcomes

Acute Emetic Episodes

More specifically, the number of episodes of vomiting on Day 1.

Time frame: 1 day

Severity of nausea

The severity of acute nausea on day 1 of treatment.

Time frame: 1 day

Delayed severe nausea

The delayed number severe nausea episodes on days 2-5.

Time frame: 5 days

Delayed emetic episodes

Looking at the number of delayed emetic episodes during days 2-5 of treatment.

Time frame: 5 days

Rescue Medication Use

Will look at the use of rescue medication throughout treatment.

Time frame: 1 month

Data from ClinicalTrials.gov

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