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
| Autor: | Francesco Agustoni, Cristiana Bergamini, F. Montanaro, Paolo Bossi, Diego Cortinovis, P. Bidoli, Fabio Macchi, Roberta Granata, Franco Nolè, M.A. Pessi, Carla B. Ripamonti, Salvatore Alfieri, M. Cossu Rocca, Alessandra Fabi, S. Fatigoni, Fausto Roila, P. Seminara, L. Michellini |
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| Přispěvatelé: | Bossi, P, Cortinovis, D, Fatigoni, S, Cossu Rocca, M, Fabi, A, Seminara, P, Ripamonti, C, Alfieri, S, Granata, R, Bergamini, C, Agustoni, F, Bidoli, P, Nolè, F, Pessi, M, Macchi, F, Michellini, L, Montanaro, F, Roila, F |
| Rok vydání: | 2017 |
| Předmět: |
Male
medicine.medical_specialty Vomiting ginger medicine.drug_class Nausea Ginger Extract medicine.medical_treatment Population Scientific evidence Antineoplastic Agents Placebo Herbal therapies 03 medical and health sciences 0302 clinical medicine Double-Blind Method Neoplasms Internal medicine medicine Humans Antiemetic chemotherapy-induced nausea and vomiting 030212 general & internal medicine Cancer Dietary supplementation education education.field_of_study Chemotherapy Dose-Response Relationship Drug Plant Extracts business.industry Hematology Middle Aged Oncology 030220 oncology & carcinogenesis Anesthesia Antiemetics Female Cisplatin Herbal therapie medicine.symptom business Chemotherapy-induced nausea and vomiting |
| Zdroj: | Annals of Oncology. 28:2547-2551 |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/annonc/mdx315 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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