Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant
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.
Detailed Description
OBJECTIVES:
-
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.
-
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
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:
Other: survey administration
Correlative studies
Procedure: management of therapy complications
Ondansetron IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
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.- 2247.00
- NCI-2010-00325
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
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
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 |
lholmber@fredhutch.org |
- 2247.00
- NCI-2010-00325