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

NCT ID: NCT00982995

Last Updated: 2015-12-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-05-31

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 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.

Conditions

Nausea; Vomiting; Terminally Ill

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Palonosetron

Palonosetron 0.25 mg I.V. bolus

Group Type: EXPERIMENTAL

Palonosetron

Intervention Type: DRUG

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.

Interventions

Palonosetron

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 Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Urba, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

UMCC 2008.048

Identifier Type: -

Identifier Source: org_study_id