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Brief Title: Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
Official Title: Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
Study ID: NCT00475085
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 Description: 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, placebo-controlled, double-blind, multicenter study. Patients are stratified according to CCOP center and gender. Patients are randomized to 1 of 4 treatment arms. Patients receive study treatment approximately 30 minutes before their scheduled first chemotherapy treatment. * Arm I: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3. * Arm II: Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3. * Arm III: Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3. * Arm IV: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3. Quality of life is assessed at baseline and on day 4. Nausea and vomiting, fatigue, sleep quality, exercise, and the need for rescue medication (metoclopramide) are assessed on days 1-4. PROJECTED ACCRUAL: A total of 890 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
MBCCOP - Gulf Coast, Mobile, Alabama, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Wichita, Wichita, Kansas, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota, St. Louis Park, Minnesota, United States
CCOP - Kansas City, Kansas City, Missouri, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States
CCOP - North Shore University Hospital, Manhassett, New York, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, United States
CCOP - Columbus, Columbus, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Northwest, Tacoma, Washington, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Name: Joseph A. Roscoe, PhD
Affiliation: James P. Wilmot Cancer Center
Role: PRINCIPAL_INVESTIGATOR