NCT00795769 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2017-05-23

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 21 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
intervention Names
Drug: ondansetron
Other: survey administration
Procedure: management of therapy complications
label
Ondansetron therapy
type
EXPERIMENTAL

interventions

arm Group Labels
Ondansetron therapy
description
Given IV
name
ondansetron
other Names
GR 38032F
GR-C507/75
Zofran
type
DRUG
arm Group Labels
Ondansetron therapy
description
Correlative studies
name
survey administration
type
OTHER
arm Group Labels
Ondansetron therapy
description
Ondansetron IV
name
management of therapy complications
other Names
complications of therapy, management of
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 49
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
time Frame
Baseline up to 120 minutes

Full 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: 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.

Source references

Source notices and limitations

Discovery and provenance

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ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Juvenile+Myelomonocytic+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
payload sha256
d39485e760a1d128b2cd2a251d4ea1122c950f2692fe29dcc6846128d2074ac1
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-ebeae47f8358072fe2e5
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00795769
occurrences
context exact
NCT00795769
end
11
exact text
NCT00795769
start
0
offset unit
unicode_code_points
query cond
Juvenile Myelomonocytic Leukemia
query disease state id
ds-juvenile-myelomonocytic-leukemia
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
source file sha256
cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
source json pointer
/studies/53/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
c7d9fc815c4f58cd0028ba4e63f8af855012756645f4c09937b1981bee65a270
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Juvenile+Myelomonocytic+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice