A preliminary randomized controlled trial of a ginger-containing, clear, fat-free oral nutritional Supplement for chemotherapy-induced nausea and nutritional outcomes

Purpose: Chemotherapy-induced nausea and vomiting (CINV) is a serious side effect, affecting approximately 40% of cancer patients and often hindering their ability to continue treatment. In this study, we evaluated the efficacy of an oral nutrition supplement (ONS) designed to decrease patients experiencing CINV. Methods: A total of 98 patients were assessed for eligibility, and 75 patients were prospectively and randomly assigned to one of three groups: the control group without ONS (Control; n = 25), a fat-free clear ONS including ginger extract group (Ginger ONS; n = 25), or the Conventional ONS group (Conv ONS; n = 25). Data collection included Numerical Rating Scale (NRS) for nausea, number of vomiting episodes, use of antiemetic drugs, blood biochemical tests, serum substance P levels, Quality of Life (QOL) Assessment, and dietary intake. Results: NRS for nausea scores after the second cycle of chemotherapy were 7.8 ± 1.8 in the Control group, 3.5 ± 1.4 in the Ginger ONS group, and 5.7 ± 1.9 in the Conv ONS group. Substance P levels decreased significantly in the Ginger ONS group compared to the Conv ONS and Control groups. In addition, the Ginger ONS group showed a significant improvement in energy and protein intake. Body weight and lean body mass were also improved. Finally, QOL was significantly improved in the Ginger ONS group following the second cycle of chemotherapy (P < 0.05). Conclusions: Taken together, these data suggest that Ginger ONS is associated with improvements in nausea and energy/protein intake following chemotherapy. It is possible that comprehensive differences in nutritional composition—including the ginger extract, the amount and quality of protein, absence of fat, palatability, etc.—may have contributed to the observed outcomes. Trial Registry: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060201.