Effect of a Standardized Ginger Root Powder Regimen on Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial - 19/02/24
, Skye Marshall, PhD 1, 2, 3, ∗, Elizabeth Isenring, PhD 1, 2, 3, ∗, Anna Lohning, PhD 1, Alexandra L. McCarthy, PhD 4, Alex Molassiotis, PhD 5, 10, Robert Bird, MD 6, Catherine Shannon, MD 7, Andy Koh, PhD 8, 11, Ian McPherson, BPharm 6, Wolfgang Marx, PhD 1, 9Abstract |
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 |
One hundred three 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 84 mg/day active gingerols/shogaols), or placebo, were administered commencing the day of chemotherapy and continuing for 5 days for chemotherapy cycles 1 through 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 analysis of variance 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 P= 0.003.
Results |
One hundred three 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 η2 = 0.09), overall CINV-related QoL (F[df] = 12.26[1,101]; P < 0.001; partial η2 = 0.11), delayed nausea severity (F[df] = 9.46[1,101]; P = 0.003; partial η2 = 0.09), and fatigue (F[df] = 10.11[1,101]; P = 0.002; partial η2 = 0.09). There was a clinically meaningful lower incidence of delayed nausea and vomiting in the ginger group at Cycle 2 (53% vs 75%; P = 0.020 and 4% vs 27%; P = 0.001, respectively) and Cycle 3 (49% vs 79%; P = 0.002 and 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 Patient-Generated Subjective Global Assessment (F[df)] = 4.32[1,100]; P = 0.040; partial η2 = 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, or 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.
Le texte complet de cet article est disponible en PDF.Keywords : Chemotherapy-induced nausea and vomiting, CINV, Nausea and vomiting, Ginger, Chemotherapy
Plan
| Supplementary materials:Table 1, Table 2, Table 4, and Table 8 are available at www.jandonline.org/ |
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| STATEMENT OF POTENTIAL CONFLICT OF INTEREST All third parties, including Bluebonnet Nutrition Corporation and The University of Sydney, were not affiliated with the study beyond commercial services. A. Molassiotis declares grants and honoraria from Helsinn. |
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| FUNDING/SUPPORT This project was funded by a competitive Cancer Council Queensland Research Project Grant (No. APP1126733). Cancer Council Queensland had no input in the study design or implementation, or analysis and reporting of results. This work was completed in partial fulfillment of M. Crichton’s PhD candidature, which was supported by a Commonwealth Government of Australia Scholarship. This trial was registered with the Australia New Zealand Clinical Trials Registry (ACTRN12616000416493p) and Therapeutic Goods Administration in Australia (CT-2017-CTN-02280-1 v2). |
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| AUTHOR CONTRIBUTIONS M. Crichton, S. Marshall, E. Isenring, A. Lohning, A. L. McCarthy, A. Molassiotis, R. Bird, C. Shannon, I. McPherson, and W. Marx designed the research; M. Crichton, A. Lohning, and A. Koh conducted the research; M. Crichton performed statistical analysis; M. Crichton drafted the paper and all other authors reviewed manuscript drafts; and W. Marx had primary responsibility for final content. All authors read and approved the final manuscript. |
Vol 124 - N° 3
P. 313 - mars 2024 Retour au numéro
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