Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Ondansetron
Intervention description: Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.
Intervention MeSH terms: Ondansetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.