Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)

This is an interventional prevention trial for Nausea focused on measuring nausea, vomiting, radiation, anti-emetic drug Read More

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.