Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting
Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting
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.
Inclusion Criteria:

 -  Informed consent

 -  Patient will receive palliative radiation therapy considered emetogenic for bone
 metastases.

 -  Group 1: At least mild nausea and/or at least mild vomiting as recorded in the
 Baseline Nausea and Vomiting Data Collection Sheet

 -  Group 2: Nausea and vomiting recorded as 'none' in the Baseline Nausea and Vomiting
 Data Collection Sheet

 Exclusion Criteria:

 -  Patient is scheduled to receive cranial radiation therapy during or within 10 days
 following completion of protocol RT.

 -  Patient received cranial RT within 7 days prior to commencement of protocol RT.

 -  Patient is scheduled to receive chemotherapy during or within 10 days following
 completion of protocol RT.

 -  Patient received moderately or highly emetogenic chemotherapy within 7 days prior to
 commencement of protocol RT.

 -  Patient is scheduled to change regimen/dose or start the use of corticosteroids
 (inhaled or topical permitted), or other medications considered to have antiemetic
 activity within 48 hours of protocol RT.

 -  Patient is scheduled to change regimen/dose or start the use of corticosteroids
 (inhaled or topical permitted), or other medications considered to have antiemetic
 activity during or within 10 days following completion of protocol RT.

 -  Patient is allergic to protocol medication.

 -  Patient has a Karnofsky Performance Status score <40.

 -  Patient is a woman who is pregnant or of childbearing potential and is not using
 contraceptive measures.