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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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 firs
Sponsor: Vanderbilt-Ingram Cancer Center

Current Primary Outcome: Control of nausea and vomiting [ Time Frame: Day 1 and Day 7 ]

Original Primary Outcome: Control of nausea and vomiting

Current Secondary Outcome:

  • Quality of life [ Time Frame: Day 1 and Day 7 ]
  • Pain control [ Time Frame: Day 1 and Day 7 ]
  • Mood [ Time Frame: Day 1 and Day 7 ]
  • Global satisfaction [ Time Frame: Day 1 and Day 7 ]


Original Secondary Outcome:

  • Quality of life
  • Pain control
  • Mood
  • Global satisfaction


Information By: Vanderbilt-Ingram Cancer Center

Dates:
Date Received: July 10, 2007
Date Started: August 2007
Date Completion:
Last Updated: March 29, 2013
Last Verified: March 2013