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Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients (HUM21469)

Primary Purpose

Nausea, Vomiting, Terminally Ill

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Palonosetron
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Palonosetron

Arm Description

Palonosetron 0.25 mg I.V. bolus

Outcomes

Primary Outcome Measures

To Determine the Complete Response (no Vomiting and no Need for Nausea Rescue Medication) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron.

Secondary Outcome Measures

To Determine the Partial Response (Relief of Nausea and Vomiting to the Extent That the Patient Desires Continued Dosing With Palonosetron,) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron

Full Information

First Posted
September 21, 2009
Last Updated
November 5, 2015
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00982995
Brief Title
Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients
Acronym
HUM21469
Official Title
UMCC 2008.048 Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
site terminated due to lack of enrollment
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Terminally Ill

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palonosetron
Arm Type
Experimental
Arm Description
Palonosetron 0.25 mg I.V. bolus
Intervention Type
Drug
Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
To Determine the Complete Response (no Vomiting and no Need for Nausea Rescue Medication) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron.
Time Frame
96 hours after dosing
Secondary Outcome Measure Information:
Title
To Determine the Partial Response (Relief of Nausea and Vomiting to the Extent That the Patient Desires Continued Dosing With Palonosetron,) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron
Time Frame
96 hours after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Urba, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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

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