Effectiveness of Aprepitant in Addition to Ondansetron in the Prevention of Nausea and Vomiting Caused by Upper Abdominal Radiotherapy

Phase 2 Completed 52 enrolled University of Vermont Mayo Clinic · collab Norris Cotton Cancer Center · collab University of Massachusetts, Worcester · collab Wake Forest University Health Sciences · collab

NaSingle-groupOpen-labelTreatment

Summary

Severe nausea and/or vomiting in patients receiving radiotherapy to the upper abdomen is common despite having received pre-medication with ondansetron, a standard preventive treatment. This study aims to reduce the incidence of significant nausea and/or vomiting with the addition of the NK1-antagonist aprepitant to standard ondansetron treatment. This study will also assess the safety and tolerability of prolonged administration of aprepitant over the 4 to 6 week period of radiation treatment.

Timeline

Start: 2009-10
Primary completion: 2016-07-01
Completion: 2016-08-01

Publications

Ades S, Halyard M, Wilson K, Ashikaga T, Heimann R, Kumar S, Blackstock W. Effectiveness of aprepitant in addition to ondansetron in the prevention of nausea and vomiting caused by fractionated radiotherapy to the upper abdomen (AVERT). Support Care Cancer. 2017 May;25(5):1503-1510. doi: 10.1007/s00520-016-3540-4. Epub 2016 Dec 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aprepitant	Other / unclassified	80 mg	Oral
Background	Ondansetron	Other / unclassified	8 mg	Oral

Indications

No indication recorded.