Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)
Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)
This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis
 or rescue of single or multiple fraction radiation induced nausea and vomiting. This
 prospective study employs a parallel arm design, allowing for inclusion of patients with
 pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients
 receiving radiotherapy known to have a low or moderate emetogenic risk will receive every
 other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use of
 rescue medication, and impact on quality of life will be monitored during and after radiation
 treatment completion.
Inclusion Criteria:

 -  Informed consent

 -  Patient will receive radiation therapy to considered moderate risk (upper abdomen,
 upper and half body irradiation) or low risk (lower thorax and pelvis) emetogenic
 palliative radiotherapy.

 -  Patients will be grouped according to nausea and vomiting status at baseline as
 follows:

 -  Group 1: Patient is experiencing no nausea and vomiting at baseline

 -  Group 2: Patient is experiencing at least mild nausea and/or at least mild
 vomiting at baseline

 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 low dose
 corticosteroids (inhaled or topical permitted), or other medications considered to
 have antiemetic properties within 48 hours prior to protocol RT.

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

 -  Concurrent use of corticosteroids during protocol RT is not permitted, unless low dose
 corticosteroids (hydrocortisone) are used for cancer treatment

 -  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.