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
Menée en Italie sur 244 patients atteints de cancer, cette étude randomisée évalue l'efficacité de l'ajout d'un extrait de gingembre à un traitement standard antiémétique, pour prévenir les nausées et vomissements induits par une chimiothérapie à base de hautes doses de cisplatine
Background: The 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 methods: We 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 (FLIE) questionnaires. The main objective was protection from delayed nausea; secondary endpoints included intercycle nausea and nausea anticipatory symptoms. Results: In 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 2 arms in the 1st cycle and 2nd cycle. A benefit of ginger over placebo in FLIE nausea score differences (day 6-day 1) was identified for females (P=0.048) and HNC patients (P=0.038) Conclusions: In 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.