Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients
Condition: Nausea; Vomiting; Terminally Ill
MeSH terms: Nausea; Vomiting
Intervention: Palonosetron
Intervention description: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief.
Intervention MeSH terms: Palonosetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the complete response (no vomiting and no
      need for other medications to treat nausea) in terminally ill patients suffering from nausea
      and/or vomiting, who are treated with palonosetron. Another objective is to determine the
      partial response (relief of nausea and vomiting to the extent that the patient wishes to
      continue treatment with palonosetron) after being treated with palonosetron. Palonosetron is
      currently approved by the FDA to prevent nausea and vomiting associated with chemotherapy.
      The investigators are testing this medication to see if it can help to relieve nausea and
      vomiting not associated with chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient must be at least 18 years old.

          2. Patient must have a terminal diagnosis, with estimated survival of 6 months or less.

          3. Patients must have nausea and/or vomiting, not relieved with 1 or more anti-nausea
             medications. If the patient is treated with an anti-nausea medication, a minimum of 2
             hours should pass to ensure that the medication is given a chance to be effective. If
             there is no relief after 2 hours, then the patient may be treated with palonosetron.

          4. Patient's medications must be reviewed. Any medications possibly causing nausea should
             be stopped if possible. For example, if an opiate is suspected of causing nausea,
             another opiate should be substituted. However, if this is not effective, or if a
             medication change cannot be made, then the patient would be eligible for this study.

          5. Patient must be able to understand and sign informed consent

          6. Patients who have a bowel obstruction that will not be relieved by surgery may be
             enrolled. This includes patients whose obstruction is technically unresectable, or who
             are medically too ill to endure a surgery, or who refuse surgical intervention for any
             reason

        Exclusion Criteria:

          1. Patient has received chemotherapy in the past 28 days.

          2. Assessment of possible causes of the nausea and vomiting should be done and recorded.
             If a reversible cause of the nausea is identified, that cause should be treated if
             possible. If the treatment relieves the nausea, then the patient is excluded from this
             study. Possible reversible causes of nausea and vomiting that should be excluded are:

               -  Other medical conditions such as benign positional vertigo, etc.