Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant

Fred Hutchinson Cancer Center49 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion * Autologous PBSC transplant patient * 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

Outcomes

Primary Outcomes

Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)

Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.

Time frame: Baseline up to 120 minutes