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

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00795769
Collaborator
(none)
49
1
1
10.1
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ondansetron
  • Other: survey administration
  • Procedure: management of therapy complications
Phase 2

Detailed Description

OBJECTIVES:
  1. 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.

  2. 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
Actual Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells
Actual Study Start Date :
Aug 8, 2008
Actual Primary Completion Date :
Jun 9, 2009
Actual Study Completion Date :
Jun 10, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ondansetron therapy

Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.

Drug: ondansetron
Given IV
Other Names:
  • GR 38032F
  • GR-C507/75
  • Zofran
  • Other: survey administration
    Correlative studies

    Procedure: management of therapy complications
    Ondansetron IV
    Other Names:
  • complications of therapy, management of
  • Outcome Measures

    Primary Outcome Measures

    1. Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates) [Baseline up to 120 minutes]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center

    Investigators

    • Principal Investigator: Leona Holmberg, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leona Holmberg, Principal Investigator, Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00795769
    Other Study ID Numbers:
    • 2247.00
    • NCI-2010-00325
    First Posted:
    Nov 21, 2008
    Last Update Posted:
    May 23, 2017
    Last Verified:
    Apr 1, 2017

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Ondansetron Therapy
    Arm/Group Description 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
    Period Title: Overall Study
    STARTED 49
    COMPLETED 49
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Ondansteron Therapy
    Arm/Group Description 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
    Overall Participants 49
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    43
    87.8%
    >=65 years
    6
    12.2%
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    52
    Sex: Female, Male (Count of Participants)
    Female
    20
    40.8%
    Male
    29
    59.2%
    Region of Enrollment (participants) [Number]
    United States
    49
    100%

    Outcome Measures

    1. Primary Outcome
    Title Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
    Description Nausea Multinational Association of Supportive Care in Cancer Antiemesis Toolâ„¢ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.
    Time Frame Baseline up to 120 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Ondansetron Therapy
    Arm/Group Description Patients receive 16mg 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
    Measure Participants 49
    MAT score >2 on arrival and pre-ondansetron
    23
    46.9%
    Baseline MAT score >2 prior to first ASCT infusion
    9
    18.4%
    MAT score increases >2 by end of infusion
    12
    24.5%
    Number of patients that vomited
    9
    18.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ondansetron Therapy
    Comments 18% n=9 of the patients vomited compared to the FHCRC historic rate of 28%. p=0.03. PMID: 21372706 reference for historical data at FHCRC.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments
    Method t-test, 1 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ondansetron Therapy
    Comments Twelve patients (24%) had a greater than two-point increase in MAT score for nausea from baseline by the end of their infusion. That rate compares to the FHCRC historic rate of 58% (p <0.0001). PMID: 21372706 reference for historical data at FHCRC
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 1 sided
    Comments

    Adverse Events

    Time Frame 11 months between August 2008-June 2009
    Adverse Event Reporting Description
    Arm/Group Title Ondansteron Therapy
    Arm/Group Description Patients receive 16 mg 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
    All Cause Mortality
    Ondansteron Therapy
    Affected / at Risk (%) # Events
    Total 0/49 (0%)
    Serious Adverse Events
    Ondansteron Therapy
    Affected / at Risk (%) # Events
    Total 0/49 (0%)
    Other (Not Including Serious) Adverse Events
    Ondansteron Therapy
    Affected / at Risk (%) # Events
    Total 18/49 (36.7%)
    Gastrointestinal disorders
    nausea 9/49 (18.4%)
    nausea and vomiting 3/49 (6.1%)
    vomiting 6/49 (12.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Leona A. Holmberg
    Organization Fred Hutchinson Cancer Research Center
    Phone 206-667-6447
    Email lholmber@fredhutch.org
    Responsible Party:
    Leona Holmberg, Principal Investigator, Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00795769
    Other Study ID Numbers:
    • 2247.00
    • NCI-2010-00325
    First Posted:
    Nov 21, 2008
    Last Update Posted:
    May 23, 2017
    Last Verified:
    Apr 1, 2017