title: A phase II randomized double-blind placebo-controlled study of 6-gingerol as an anti-emetic in solid tumor patients receiving moderately to highly emetogenic chemotherapy.
abstract: 6-Gingerol is a natural compound extracted from ginger. Preclinical studies demonstrated that 6-gingerol has an anti-emetic activity by inhibiting neurokinin-1, serotonin, and dopamine receptors. Several clinical trials examined crude ginger powder for preventing chemotherapy-induced nausea and vomiting (CINV), but none of them was conducted with a standardized bioactive compound. Patients who received moderately to highly emetogenic adjuvant chemotherapy were randomized to receive 6-gingerol 10 mg or placebo orally twice daily for 12 weeks. Ondansetron, metoclopramide, and dexamethasone were given to all patients. The primary endpoint was complete response (CR) rate defined as no emesis or rescue treatment at any time. Eighty-eight patients were randomized to receive 6-gingerol (N = 42) or placebo (N = 46). Most patients received highly emetogenic chemotherapy (93%). Overall CR rate was significantly higher in 6-gingerol group as compared with that of the placebo (77 vs. 32%; P < 0.001). The difference in means of appetite score was significant (P = 0.001) and more noticeable over time. Mean FACT-G score indicating quality of life was significantly higher (86.21) in 6-gingerol group at 64 days as compared with that of placebo group (72.36) (P < 0.001). No toxicity related to 6-gingerol was observed. Patients treated with 6-gingerol reported significantly less grade 3 fatigue (2 vs. 20%; P = 0.020). 6-Gingerol significantly improved overall CR rate in CINV, appetite and quality of life in cancer patients receiving adjuvant chemotherapy. A phase III randomized study of 6-gingerol is warranted to confirm these results.
authors.affiliation: Department of Pharmacy, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.|Center for Research and Development of Herbal Health Products, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.|The College of Pharmacotherapy of Thailand, Nonthaburi, Thailand.
authors.forename: J
authors.initials: J
authors.lastname: Konmun
authors.affiliation: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanuloke, Thailand.|The College of Pharmacotherapy of Thailand, Nonthaburi, Thailand.
authors.forename: K
authors.initials: K
authors.lastname: Danwilai
authors.affiliation: Medical Oncology Unit, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: N
authors.initials: N
authors.lastname: Ngamphaiboon
authors.affiliation: Center for Research and Development of Herbal Health Products, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: B
authors.initials: B
authors.lastname: Sripanidkulchai
authors.affiliation: Medical Oncology Unit, Department of Medicine, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: A
authors.initials: A
authors.lastname: Sookprasert
authors.affiliation: Center for Research and Development of Herbal Health Products, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand. supsub2@kku.ac.th.|Clinical Pharmacy Division, Faculty of Pharmaceutical Sciences, Khon Kaen University, 123 Mittraphap road, Khon Kaen, 40002, Thailand. supsub2@kku.ac.th.|The College of Pharmacotherapy of Thailand, Nonthaburi, Thailand. supsub2@kku.ac.th.
authors.forename: S
authors.initials: S
authors.lastname: Subongkot
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002396:Catechols / Q000627:therapeutic use*; D004311:Double-Blind Method; D005233:Fatty Alcohols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D018943:Anthracyclines; D000932:Antiemetics; D002396:Catechols; D005233:Fatty Alcohols; D009944:Organoplatinum Compounds; C007845:gingerol
keywords: 6-Gingerol; CINV; Chemotherapy; Ginger; Nausea