Safety and availability of functional food containing superfine dispersed Lentinan (β-1,3-glucan) in cancer patients - Multi-central unified protocol clinical trial

摘要

Lentinan, V fully purified β-1,3-glucan with Pβ-1,6 branches from Lentinus edodes, was approved as an anticancer drug for inoperable and recurrent gastric cancer patients in Japan in 1985. Lentinan has life prolongation effects and quality of life (QOL) improvement effects mediated the augmentation of host-immune systems in cancer patients. Recently, functional food containing a certain amount of superfine dispersed Lentinan for oral administration, was researched and developed. In this study, we investigated safety and availability of this functional food as a supplementary food for cancer patients by multi-central unified protocol clinical study. In terms of test food safety, 10 adverse effects were observed in 315 patients by the ingestion of test food. There were no severe cases, and all symptoms disappeared within the observation periods. It was concluded that the test food was completely free of anything harmful. In terms of usefulness, the test food suppressed the frequency of adverse effects (leucopenia) by chemotherapeutics. And the improvement of QOL, clinical laboratory test values and nutritional state were observed. Availabilities of this test food as a supplementary food for cancer patients were confirmed.