Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy
Withdrawn before enrolling · Not applicable
Conditions studied: Nausea, Vomiting
In brief
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.
Key facts
- Study ID
- NCT01980160
- Run by
- Christiana Care Health Services
- People needed
- 0
- Starts
- 2013-11-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2015-10-02
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
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
- 18 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.
Where it is running
- Helen F. Graham Cancer Center — Newark, Delaware, United States
Full record on ClinicalTrials.gov
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