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Randomized Controlled Trial Multicenter Study
A randomized, double-blind, placebo-controlled, multicenter study of a ginger extract in the management of chemotherapy-induced nausea and vomiting (CINV) in patients receiving high-dose cisplatin.
- P Bossi, D Cortinovis, S Fatigoni, M Cossu Rocca, A Fabi, P Seminara, C Ripamonti, S Alfieri, R Granata, C Bergamini, F Agustoni, P Bidoli, F Nolè, M A Pessi, F Macchi, L Michellini, F Montanaro, and F Roila.
- Head and Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Scientific Direction, Latis Cro, Genova, Milano;. Electronic address: paolo.bossi@istitutotumori.mi.it.
- Ann. Oncol. 2017 Oct 1; 28 (10): 2547-2551.
BackgroundThe activity of ginger in the management of chemotherapy-induced nausea and vomiting (CINV) has been suggested, but design inadequacies, heterogeneity of the population, small numbers and poor quality of tested products limit the possibility to offer generalizable results.Patients And MethodsWe conducted a randomized, double-blind, placebo-controlled, multicenter study in patients planned to receive ≥2 chemotherapy cycles with high dose (>50 mg/m2) cisplatin. Patients received ginger 160 mg/day (with standardized dose of bioactive compounds) or placebo in addition to the standard antiemetic prophylaxis for CINV, starting from the day after cisplatin administration. CINV was assessed through daily visual-analogue scale and Functional Living Index Emesis questionnaires. The main objective was protection from delayed nausea; secondary end points included intercycle nausea and nausea anticipatory symptoms.ResultsIn total, 121 patients received ginger and 123 placebo. Lung (49%) and head and neck cancer (HNC; 35%) were the most represented tumors. No differences were reported in terms of safety profile or compliance. The incidence of delayed, intercycle and anticipatory nausea did not differ between the two arms in the first cycle and second cycle. A benefit of ginger over placebo in Functional Living Index Emesis nausea score differences (day 6-day 1) was identified for females (P = 0.048) and HNC patients (P = 0.038).ConclusionsIn patients treated with high-dose cisplatin, the daily addition of ginger, even if safe, did not result in a protective effect on CINV. The favorable effect observed on nausea in subgroups at particular risk of nausea (females; HNC) deserves specific investigation.© The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
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