Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-29 @ 7:41 AM
Study NCT ID:
NCT00499668
Status:
WITHDRAWN
Last Update Posted:
2013-04-02
First Post:
2007-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting
Status:
WITHDRAWN
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: