Clinical trial NCT01980160: Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nausea
Vomiting
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Neurowave Medical Technologies
First posted: 2013-11-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Number of episodes of Vomiting
timeFrame: 1 month
measure: Severity of Nausea
timeFrame: 1 month
Secondary outcomes:
measure: Acute Emetic Episodes
timeFrame: 1 day
measure: Severity of nausea
timeFrame: 1 day
measure: Delayed severe nausea
timeFrame: 5 days
measure: Delayed emetic episodes
timeFrame: 5 days
measure: Rescue Medication Use
timeFrame: 1 month
Other outcomes:
Locations:
city: Newark
country: United States
facility: Helen F. Graham Cancer Center
state: Delaware
Study officials:
References:
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