A small pilot study of the fermented soybean extract MicrSoy-20(MS-20) demonstrated its ability to restore chemotherapy-induced immunosuppression and improve quality of life (QoL). This randomized, cross-over, comparative trial was conducted to confirm the effects of MS-20 on QoL and to understand its underlying mechanism when used in conjunction with chemotherapy. One hundred forty-three patients undergoing cancer chemotherapy were randomly assigned to 2 groups. Group 1 was administered MS-20 for 1 wk followed by 3 wk of concomitant MS-20 plus chemotherapy. Group 2 was administered chemotherapy for 3 wk. QoL was assessed by the EORTC/QLQ-C30 questionnaire and visual analogue scales (VAS). Changes in immunological parameters and antioxidant profiles were also examined. Significant increases were observed in EORTC/QLQ-C30 scores for physical (4.45, P = 0.023) and social (3.99, P = 0.023) functioning in Group 1 patients compared to Group 2 patients. VAS scores for fatigue and appetite loss significantly improved with MS-20 treatment (P < 0.001). Group 1 patients exhibited smaller decreases in peripheral blood mononuclear cells compared to Group 2 patients (P = 0.026). Other immunological parameters, antioxidant, and safety profiles were not significantly different between treatment groups. Addition of MS-20 as an adjuvant to chemotherapy can be effective in improving QoL for cancer patients.
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