Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients



Status:Terminated
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2010
End Date:May 2013

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UMCC 2008.048 Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients

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.


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.
We found this trial at
1
site
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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