Effect of a standardized ginger root powder regimen on chemotherapy-induced nausea and vomiting: a multi-center double-blind placebo-controlled randomized trial

BACKGROUND: There is substantial interest in the role of ginger as an adjuvant therapy for chemotherapy-induced nausea and vomiting (CINV). However, available evidence lacks robust methodology.

OBJECTIVE: To assess the effect of adjuvant ginger compared with placebo on chemotherapy-induced nausea-related quality of life (QoL) and CINV-related outcomes.

DESIGN: A parallel double-blind, placebo-controlled randomized trial with 1:1 allocation was conducted.

PARTICIPANTS: /setting: N=103 chemotherapy-naïve adults scheduled to receive moderately-to-highly emetogenic chemotherapy at two hospitals in Australia were enrolled and analyzed.

INTERVENTION: Four standardized ginger capsules (totaling 84mg/day of active gingerols/shogaols), or placebo, were administered commencing the day of chemotherapy and continuing for 5-days for chemotherapy Cycles 1-3.

MAIN OUTCOME MEASURES: The primary outcome was chemotherapy-induced nausea-related QoL. Secondary outcomes were vomiting- and CINV-related QoL; anticipatory, acute, and delayed nausea and vomiting; fatigue; nutritional status; depression and anxiety; health-related QoL; and adverse events.

STATISTICAL ANALYSES PERFORMED: Intention-to-treat analysis was performed. Mixed RMANOVA with repeated measures determined differences between groups. The null hypothesis was no difference between groups. After applying a Bonferroni multiple testing correction, evidence against the null hypothesis was considered at the p-value of 0.003.

RESULTS: N=103 participants (ginger: n=52; placebo: n=51) were enrolled and analyzed. There was clinically relevant evidence against the null hypothesis, favoring ginger, in change scores for nausea-related QoL (F(df)=9.34(1,101), p=0.003, partial η 2=0.09), overall CINV-related QoL (F(df)=12.26(1,101), p<0.001, partial η 2=0.11), delayed nausea severity (F(df)=9.46(1,101), p=0.003, partial η 2=0.09), and fatigue (F(df)=10.11(1,101), p=0.002, partial η 2=0.09). There was a clinically meaningful lower incidence of delayed nausea and vomiting in the ginger group at Cycles 2 (53% vs. 75%, p=0.020; 4% vs. 27%, p=0.001, respectively) and 3 (49% vs. 79%, p=0.002; 2% vs. 23%, p=0.001, respectively). There was a clinically meaningful lower incidence of malnutrition in the ginger group at Cycle 3 (18% vs. 41%, p=0.032) and in change scores for PG-SGA (F(df)=4.32(1,100), p=0.040, partial η 2=0.04). Change scores between groups favored ginger for vomiting-related QoL and number of vomiting episodes; however, findings were not clinically meaningful. There was no effect of ginger on anticipatory or acute CINV, health-related QoL, anxiety, nor depression. No serious adverse events were reported.

CONCLUSIONS: Ginger supplementation was a safe adjuvant to antiemetic medications for CINV that enhanced QoL during chemotherapy treatment. Future trials are needed to examine dose-dependent responses to verify optimal dosing regimens.