Clinical Trial: Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

Brief Summary:

RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy.

PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.


Detailed Summary:

OBJECTIVES:

Primary

  • Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by prochlorperazine with vs without dexamethasone in preventing delayed nausea in women with chemotherapy-naive breast cancer. (Arms I and IV)
  • Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride in controlling treatment-related delayed nausea in these patients. (Arms I and II)
  • Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for controlling treatment-related delayed nausea in these patients. (Arms III and IV)

Secondary

  • Determine if the addition of dexamethasone to prochlorperazine is more effective than the same regimen without dexamethasone for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and IV)
  • Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and II)
  • Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for reducing interference with functioning due to chemotherapy-induced nausea and vomiting in these patients. (Arms III and IV)

OUTLINE: This is a randomized
Sponsor: Joseph Roscoe

Current Primary Outcome: Home Record: Severity of Delayed Nausea [ Time Frame: average of day 1 afternoon, evening and night, and all of days 2 and 3 ]

1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse


Original Primary Outcome:

  • Severity of delayed nausea
  • Interference with functioning caused by nausea or emesis


Current Secondary Outcome:

Original Secondary Outcome: Change in quality of life score between post- and pre-treatment measurements

Information By: University of Rochester

Dates:
Date Received: May 16, 2007
Date Started: December 2006
Date Completion:
Last Updated: October 13, 2015
Last Verified: October 2015