P Bossi1, D Cortinovis2, S Fatigoni3, M Cossu Rocca4, A Fabi5, P Seminara6, C Ripamonti7, S Alfieri8, R Granata8, C Bergamini8, F Agustoni9, P Bidoli2, F Nolè4, M A Pessi7, F Macchi10, L Michellini11, F Montanaro12, F Roila3. 1. Head and Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Scientific Direction, Latis Cro, Genova, Milano;. Electronic address: paolo.bossi@istitutotumori.mi.it. 2. Medical Oncology, Ospedale San Gerardo, Monza. 3. Medical Oncology, Ospedale Santa Maria, Terni. 4. Medical Oncology, Istituto Europeo di Oncologia, Milano. 5. Medical Oncology, Istituto Nazionale Regina Elena, Roma. 6. Medical Oncology, Università Sapienza, Roma. 7. Supportive Care in Cancer Unit. 8. Head and Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Scientific Direction, Latis Cro, Genova, Milano. 9. Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. 10. Scientific & Clinical Development, Helsinn Integrative Care, Lugano, Switzerland. 11. Scientific Direction. 12. Statistical Department, Latis Cro, Genova, Italy.
Abstract
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 questionnaires. The main objective was protection from delayed nausea; secondary end points 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 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). 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.
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 questionnaires. The main objective was protection from delayed nausea; secondary end points 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 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). 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.
Authors: Nguyen Hoang Anh; Sun Jo Kim; Nguyen Phuoc Long; Jung Eun Min; Young Cheol Yoon; Eun Goo Lee; Mina Kim; Tae Joon Kim; Yoon Young Yang; Eui Young Son; Sang Jun Yoon; Nguyen Co Diem; Hyung Min Kim; Sung Won Kwon Journal: Nutrients Date: 2020-01-06 Impact factor: 5.717