Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed ChemotherapyInduced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy, NCCTG N08C3 (Alliance) Debra L. Barton, RN, PhD, AOCN1; Gita Thanarajasingam, MD1; Jeff A. Sloan, PhD2; Brent Diekmann2; Jyotsna Fuloria, MD3; Lisa A. Kottschade, RN, MSN, CNP1; Alan P. Lyss, MD4; Anthony J. Jaslowski, MD5; Miroslaw A. Mazurczak, MD6; Scott C. Blair, MD7; Shelby Terstriep, MD8; and Charles L. Loprinzi, MD1
BACKGROUND: Despite targeted antiemetics, data support an unmet need related to the management of delayed nausea and vomiting (NV). Promising pilot data informed this phase III trial evaluating gabapentin for delayed NV from highly emetogenic chemotherapy (HEC). METHODS: Participants were randomized to receive prophylactic treatment with 20 mg of dexamethasone and a 5HT3 receptor antagonist (RA) on the day of chemotherapy, followed by gabapentin 300 mg twice a day and dexamethasone (dex) or placebo and dex after HEC. Gabapentin/placebo was started the day of chemotherapy and continued through day 5 for the first chemotherapy cycle, whereas dex was titrated down on days 2-4. The primary end point was complete response (CR), defined as no emesis and no use of rescue medications on days 2-6, using an NV diary. The percentages of those in each group with a CR were compared by Fisher’s exact test. RESULTS: Four hundred thirty patients were enrolled in this study. Forty-seven percent of patients in the gabapentin arm and 41% in the placebo arm had a CR (P 5.23). Mean number of emesis episodes was
Phase III double-blind, placebo-controlled study of gabapentin for the prevention of delayed chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy, NCCTG N08C3 (Alliance).
Despite targeted antiemetics, data support an unmet need related to the management of delayed nausea and vomiting (NV). Promising pilot data informed ...
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