Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study
Status:
Terminated
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
The primary objective of this pilot study is to examine the efficacy of Aprepitant given in
combination with Granisetron for the prevention of delayed-phase RINV in 84 patients
receiving a single 8Gy of moderately emetogenic palliative RT in the RRRP at Sunnybrook
Odette Cancer Centre for painful bony metastases from any primary solid tumor. Patients will
be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least
one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings
on Days 1 and 2 following the radiation treatment.. Secondary objectives include determining
the complete RINV prophylaxis rate (acute and delayed phases), the partial emesis control
rate, the safety of the combined regime, QOL issues, the time to the first emetic event and
the time to the first use of rescue medication .