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A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting

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What is being tested

aprepitant

+ ondansetron hydrochloride
Drug
Who is being recruted

Blood Protein Disorders
+26

+ Bone Marrow Diseases
+ Cardiovascular Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: August 2007
See protocol details

Summary

Principal SponsorVanderbilt-Ingram Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2007Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * To evaluate the efficacy of aprepitant as monotherapy for opioid-induced nausea and vomiting (OINV) in comparison to ondansetron hydrochloride in patients who have failed at least one prior anti-emetic agent/regimen. Secondary * To determine whether control of OINV improves quality of life. * To determine if control in OINV decreases pain. * To determine if control in OINV improves mood. OUTLINE: Patients are randomized to 1 of 2 treatment arms. * Arm A: Patients receive aprepitant orally once daily for 7 days in the absence of unacceptable toxicity or persistent grade 4 nausea and vomiting. * Arm B: Patients receive ondansetron hydrochloride orally 3 times daily for 7 days in the absence of unacceptable toxicity or persistent grade 4 nausea and vomiting. Patients complete the following questionnaires: Functional Assessment of Cancer Therapy-General (FACT-G); Center for Epidemiologic Studies Depression Scale (CES-D); and Brief Pain Index (BPI) at baseline and on day 7. Patients also complete symptom diaries documenting the following: number of episodes (an emetic episode is defined as a simple vomit or retch, or any number of continuous vomits or retches; distinct episodes that are separated by at least 1 minute) of vomiting or retching including the date and time; worst and average degree of nausea (recorded every 2 hours while awake during the first 24 hours after treatment and every 8 hours on days 1-7); and adverse events other than episodes of vomiting and nausea.

Official TitleA Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting 
NCT00499668
Principal SponsorVanderbilt-Ingram Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Disease
Hematologic Diseases
Hemorrhagic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Multiple Myeloma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Nausea
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Pathologic Processes
Plasmacytoma
Precancerous Conditions
Preleukemia
Signs and Symptoms, Digestive
Syndrome
Vascular Diseases
Vomiting
Hemostatic Disorders
Neoplasms, Plasma Cell
Criteria

DISEASE CHARACTERISTICS: * History of malignancy (including hematological malignancies) * Has pain requiring opioid analgesics * Nausea and vomiting (associated with opioid analgesic use) that is unrelieved by at least one standard antiemetic regimen (including 5HT3 antagonist and dexamethasone combination therapy) * Patients who have failed ondansetron hydrochloride for treatment of opioid-induced nausea and vomiting will be excluded from the study PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Able to assess severity of nausea and vomiting and document it in the diary * Women must not be pregnant or lactating * Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception * Urine pregnancy test will be given to women of childbearing age * No concerns about compliance with medication regimen or medical follow-up (patient must be able to tolerate oral dosing) * No severe or chronic illness or other causes of nausea and vomiting, that in judgment of the treating physician, will place patient at risk * No severe gastrointestinal obstruction or active peptic ulcer disease * Serum ALT and AST \< 2 times upper limit of normal (ULN) * Serum bilirubin \< 2 times ULN * Serum alkaline phosphatase \< 2 times ULN PRIOR CONCURRENT THERAPY: * No surgery within the past 7 days * No chemotherapy within the past 7 days * No total or lower body radiation therapy within the past 7 days * Patient may not be scheduled to undergo total body irradiation or lower body irradiation, chemotherapy, or surgery during study participation * Patient must not be taking warfarin


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

125 mg orally for 7 days
Group II
Experimental

24 mg orally for 7 days
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 

SuspendedNo study centers