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

Christiana Care Health Services

Status: Withdrawn

Conditions: Vomiting; Nausea

Treatments: Device: Activated Nometex Device; Device: Unactivated Nometex Device

Study type: Interventional

Funder types: Other

Identifiers

NCT01980160

NMT-Nometex

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Activated Nometex Device

Active Comparator group

Description:

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.

Treatment:

Device: Activated Nometex Device

Unactivated Nometex Device

Sham Comparator group

Description:

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

Treatment:

Device: Unactivated Nometex Device