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

Nausea research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Nausea

Vomiting

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:aprepitantaprepitant 125 mg po (Mondays), 80 mg po (Wednesdays), 80 mg po (Fridays) with doses scheduled 1-2 hours prior to the day's radiation fraction. Aprepitant will not be administered on weekend days. Aprepitant administration will continue until the last day of radiotherapy.

Drug:OndansetronOndansetron 8 mg po bid, with the morning dose scheduled 1-2 hours prior to the day's radiation fraction. Ondansetron will not be administered on weekend days. Ondansetron administration will continue until the last day of radiotherapy.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Active, not recruiting

Start Date: October 2009

Completed Date: August 2016

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Complete Response rate (no vomiting and no rescue anti-emetic therapy)

Secondary Outcome: Complete Response rate

Study sponsors, principal investigator, and references

Principal Investigator: Steven Ades, MD MSc

Lead Sponsor: University of Vermont

Collaborator: Mayo Clinic

More information:https://clinicaltrials.gov/show/NCT00970905

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