Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to examine the efficacy of Ondissolve for the
prevention/rescue of Acute and Delayed Phase radiation induced nausea and vomiting (RINV) in
patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for
painful bone metastases. The study population will be 30 patients seen in the RRRP at the
Sunnybrook Odette Cancer Centre receiving palliative radiation therapy considered emetogenic
for bone metastases. Patients will take the study medication (Ondissolve 8 mg) twice on each
day of radiation therapy, at least one hour prior to treatment and repeat approximately 6-8
hours later the same day. Patients undergoing multiple fraction radiation therapy will take
Ondissolve on weekends or holidays in between treatment. Secondary objectives include to
evaluate key secondary endpoints related to RINV, and to investigate the ease and length of
administration of protocol medicine. We hypothesize that Ondissolve will be effective in the
prophylaxis of RINV, and the ease of use and administration will provide an appropriate
delivery method for those unable to tolerate the oral form of ondansetron.