Trial Outcomes & Findings for Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant (NCT NCT00795769)

NCT ID: NCT00795769

Last Updated: 2017-05-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 49 participants
• Primary outcome timeframe: Baseline up to 120 minutes
• Results posted on: 2017-05-23

Participant Flow

Participant milestones

Measure	Ondansetron Therapy 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 Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Ondansteron Therapy n=49 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 120 minutes

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.

Outcome measures

Measure	Ondansetron Therapy n=49 Participants 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
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates) MAT score >2 on arrival and pre-ondansetron	23 Participants
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates) Baseline MAT score >2 prior to first ASCT infusion	9 Participants
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates) MAT score increases >2 by end of infusion	12 Participants
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates) Number of patients that vomited	9 Participants

Adverse Events

Ondansteron Therapy

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ondansteron Therapy n=49 participants at risk 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
Gastrointestinal disorders nausea	18.4% 9/49 • 11 months between August 2008-June 2009
Gastrointestinal disorders nausea and vomiting	6.1% 3/49 • 11 months between August 2008-June 2009
Gastrointestinal disorders vomiting	12.2% 6/49 • 11 months between August 2008-June 2009

Additional Information

Dr. Leona A. Holmberg

Fred Hutchinson Cancer Research Center

Phone: 206-667-6447

Email: lholmber@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place