Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
Study Overview
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 Description
OBJECTIVES:
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to β (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ondansetron therapy
Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
Intervention: ondansetron (Drug)
Ondansetron therapy
Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
Intervention: survey administration (Other)
Ondansetron therapy
Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
Intervention: management of therapy complications (Procedure)
Outcomes
Primary Outcomes
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
Time Frame: Baseline up to 120 minutes
Nausea Multinational Association of Supportive Care in Cancer Antiemesis Toolβ’ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.
Secondary Outcomes
No secondary outcomes reported
Investigators
Leona Holmberg
Principal Investigator
Fred Hutchinson Cancer Center