Status:
TERMINATED
Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 vomiti...
Eligibility Criteria
Inclusion
- Patient must be at least 18 years old.
- Patient must have a terminal diagnosis, with estimated survival of 6 months or less.
- 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.
- 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.
- Patient must be able to understand and sign informed consent
- 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
- Patient has received chemotherapy in the past 28 days.
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00982995
Start Date
November 1 2010
End Date
May 1 2013
Last Update
December 4 2015
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109