Clinical Trial: Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells
Brief Summary:
RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing stem cell transplant.
PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant.
Detailed Summary:
OBJECTIVES:
I. To determine whether the incidence of nausea, retching 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.
Sponsor: Fred Hutchinson Cancer Research Center
Current Primary Outcome: Reduction in rates of nausea or vomiting after ondansetron (compared to historical rates) [ Time Frame: With stem cell infusion ]
Original Primary Outcome:
- Reduction of nausea to ≤ 25% and vomiting to ≤ 10% related to DMSO-preserved autologous hematopoietic stem cells
- Incidence of nausea and vomiting
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Fred Hutchinson Cancer Research Center
Dates:
Date Received: November 20, 2008
Date Started: August 2008
Date Completion:
Last Updated: August 26, 2010
Last Verified: August 2010
