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Abstract
Patients undergoing chemotherapy suffer from taste disorders that affect the quality of life (QOL). In this study, a randomized, double-blind, placebo-controlled trial was conducted to explore the effectiveness of AHCC®, a standardized extract of cultured Lentinula edodes mycelia, for chemotherapy-related adverse events and taste disorders in patients with gastrointestinal cancer. Patients who received chemotherapy were randomized to receive either placebo or AHCC®. The study endpoints were the incidence of anemia and taste disorders assessed with changes in nutritional parameters. Ninety-eight patients with pancreatic ductal adenocarcinoma (PDAC) were enrolled in this study, with 55 patients randomly assigned to the AHCC® group and 43 to the placebo group. The incidence of grades 2-3 anemia in the AHCC® group who were receiving chemotherapy was not significantly different compared to that of the placebo group (Risk difference; −3.1% [95% confidence intervals (CI): −22.8% to 16.9%], p = 0.8392). In the AHCC® group, the occurrence of taste disorders during chemotherapy was significantly lower, and the nutritional parameters were significantly improved compared to those in the placebo group (Risk difference; 28.6% [95% CI: 7.5% to 47.8%], p = 0.0077). AHCC® appears to prevent taste disorders in patients with advanced PDAC who were receiving chemotherapy. AHCC® is expected to enable patients who need chemotherapy to improve nutritional status and their QOL.
Acknowledgments
The authors thank Sae Murakami, Takashi Omori, Keiko Miyakoda, Yumi Takagi (Clinical and Translational Research Center, Kobe University Hospital, Kobe, Japan) for data analysis and Miho Ike for scoring test of gustatory function in four basic tastes. We also thank Jun Takanari and Hajime Fujii (Amino Up Co. Ltd), who had no role in the study design, data collection, data analysis, or data interpretation, for providing the AHCC® free of cost.
Author Contributions
Data curation, H.Y., S.H., S.Y., and T.Y.; Methodology, H.Y.; Supervision, M.S.; Writing original draft, H.Y.; Writing review and editing, S.H. and M.S. All authors have read and agreed to the published version of the manuscript.
Disclosure Statement
All authors declare that they have no conflict of interest.
Funding
The author(s) reported there is no funding associated with the work featured in this article.