Ovarian Cancer Clinical Trial

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

Summary

The primary study hypotheses are that, without increasing doses of breakthrough medications or device intolerance, the Nometexâ„¢ 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 Nometexâ„¢ 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study is for people with:

Ovarian Cancer

Study ID:

NCT01980160

Recruitment Status:

Withdrawn

Sponsor:

Christiana Care Health Services

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There is 1 Location for this study

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Helen F. Graham Cancer Center
Newark Delaware, 19713, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Study ID:

NCT01980160

Recruitment Status:

Withdrawn

Sponsor:


Christiana Care Health Services

How clear is this clinincal trial information?

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