Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer

Not Applicable

Withdrawn

• Conditions: Myeloproliferative Disorders; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Nausea and Vomiting; Solid Tumor
• Interventions: Drug: ondansetron hydrochloride; Drug: aprepitant

• Registration Number: NCT00499668
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

RATIONALE: Antiemetic drugs, such as aprepitant and ondansetron, may help lessen nausea and vomiting caused by opioids. It is not yet known whether aprepitant is more effective than ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.

PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Study Start: 2007-08
• Primary Completion: 2008-01
• Study Completion: 2008-03
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-29
• Last Update Posted: 2013-04-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM B	ondansetron hydrochloride	-
ARM A	aprepitant	-

Primary Outcome Measures

Name	Time	Method
Control of nausea and vomiting	Day 1 and Day 7

Secondary Outcome Measures

Name	Time	Method
Quality of life	Day 1 and Day 7
Pain control	Day 1 and Day 7
Mood	Day 1 and Day 7
Global satisfaction	Day 1 and Day 7