Efficacy Of Ginger For Chemotherapy-Induced Nausea And Vomiting (Cinv) Prophylaxis In Breast Cancer Patients Receiving Adriamycin - Cyclophosphamide (Ac) Regimen: Randomized Double-Blind Placebo Control Crossover Study.

e21621 Background: Data on efficacy of ginger for CINV prophylaxis are conflicting. Several studies observed a reduction in incidence and severity of CINV when ginger was given along with highly emetogenic chemotherapy. The objective of the study was to determine an efficacy of ginger in reducing CINV in breast cancer patients who are receiving AC regimen which has moderate emetogenicity. Methods: Breast cancer patients receiving the first cycle of AC regimen who developed moderate nausea reported by the patients using visual analog scale from 0 (no nausea) to 100 (unbearable nausea) with score at least 40 were recruited. Eligible patients were randomized to receive either 500 mg ginger capsule or placebo twice a day for 5 days starting on the first day of the second cycle of AC regimen. The patients were switched to receive another drug in the third cycle. Nausea severity and vomiting incidence were recorded once a day during the first 5 days after receiving the study medication. Ondansetron and dexamethasone were given in all cycles. Primary outcome was a reduction in nausea score. To detect a reduction of nausea score at least 20 with 5% type I error (2-sided) and 20% type II error, 34 patients were required. Results: Thirty-four patients were enrolled during February and December 2015. Mean (range) of nausea score in the first cycle of AC regimen was 58 (40-90). Thirty-three patients (97%) received same AC dose in the second and third cycle. There was no interaction between the sequence of treatment and primary outcome (p = 0.5). Mean (SE) of maximum nausea score when the patients received ginger and placebo were 35.36 (4.43) and 32.17 (3.71), respectively. The difference in mean maximum nausea score was 3 (95% confidence interval, -3 to 9; p = 0.3). There was no difference in vomiting incidence, rate of rescue medication use, incidence of chemotherapy dose reduction or delay and adverse events. Conclusions: Ginger at the study dose is safe but it confers no additional benefit in reducing nausea severity when ondansetron and dexamethasone are given for CINV prophylaxis in breast cancer patients receiving AC regimen. Clinical trial information: NCT02390648.