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

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.

Timeline

Start

2006-12

Primary completion

2012-12

Completion

—

Outcome

Mixed primary results

paper palonosetron versus granisetron: -0.01 (95% CI, -0.23 to 0.20; P = .72) PMID 22915657 ↗

paper adding dexamethasone on days 2 and 3: 0.20 (95% CI, -0.02 to 0.41; P = .01) PMID 22915657 ↗

paper using aprepitant versus prochlorperazine: -0.03 (95% CI, -0.24 to 0.19; P = .56). PMID 22915657 ↗

Publications

• Roscoe JA, Heckler CE, Morrow GR, Mohile SG, Dakhil SR, Wade JL, Kuebler JP. Prevention of delayed nausea: a University of Rochester Cancer Center Community Clinical Oncology Program study of patients receiving chemotherapy. J Clin Oncol. 2012 Sep 20;30(27):3389-95. doi: 10.1200/JCO.2011.39.8123. Epub 2012 Aug 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aprepitant	Other / unclassified	—	Oral
Subject	Dexamethasone	Small molecule	—	Oral
Subject	Granisetron	Other / unclassified	—	Oral
Subject	Palonosetron	Other / unclassified	—	Oral
Subject	Prochlorperazine	Small molecule	—	Oral

Indications

No indication recorded.