Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant
NCT ID: NCT00795769
Last Updated: 2017-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2008-08-08
2009-06-10
Brief Summary
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PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant.
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Detailed Description
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I. To determine whether the incidence of nausea and vomiting related to administration of autologous hematopoetic stem cells cryopreserved in DMSO can be reduced by the use of a single dose of intravenous ondansetron prior to the stem cell infusion.
II. To determine the number of patients who experience nausea and vomiting.
OUTLINE: Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Ondansetron therapy
Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
ondansetron
Given IV
survey administration
Correlative studies
management of therapy complications
Ondansetron IV
Interventions
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ondansetron
Given IV
survey administration
Correlative studies
management of therapy complications
Ondansetron IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English-speaking
* Planned cryopreserved PBSC infusion at the SCCA outpatient clinic
Exclusion
* History of prior autologous transplant
* Non-English-speaking
* Planned cryopreserved PBSC infusion at the UWMC inpatient unit
* Infusion of cryopreserved PBSC that are thawed and washed to remove DMSO prior to infusion
* Allergy or adverse reaction to ondansetron
21 Years
ALL
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Leona Holmberg
Principal Investigator
Principal Investigators
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Leona Holmberg
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2010-00325
Identifier Type: REGISTRY
Identifier Source: secondary_id
2247.00
Identifier Type: -
Identifier Source: org_study_id
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