Effects of Nichi BRITE β-glucans as an onco-nutrition adjuvant in patients undergoing subtotal stomach-preserving pancreaticoduodenectomy (SSPPD) for pancreatic, bile duct and duodenal malignancies: A clinical study.

OBJECTIVES

Pancreatic cancers involve several challenges from difficulty in early diagnosis to high recurrence and mortality even after therapeutic interventions. Patients who undergo a surgical resection have several postoperative complications besides recurrence. Immunosuppression in the peri-operative period is a major challenge to overcome and in this study we investigated the effects of AFO-202 strain Aureobasidium-pullulans produced β-glucan (Nichi BRITE) in patients who underwent subtotal stomach-preserving pancreaticoduodenectomy (SSPPD) for pancreatic, bile duct and duodenal malignancies.

METHODS

Thirty patients undergoing SSPPD were randomly assigned to a control (n = 15) group. A placebo was given, and the treatment arm (n = 15), administered Nichi BRITE 250 mg (Glucan) in 3 divided doses per day, starting from 1 d prior to the day of surgery up to the 21st postoperative day, either by oral intake or feeding gastrostomy. Parameters of relevance to immune system and biomarkers of cancer pathology were evaluated.

RESULTS

Among the 22 patients who completed the study, the Nichi BRITE group showed notable increases in BG-IgA (+109.09%), CD209 (+54.68%, P = 0.034), and SAA (+800.70%, P = 0.050), while CA 19-9 decreased significantly (-5.86 U/mL, P < 0.001). Decrease in CD44 levels was greater in Nichi BRITE (-35.51%) than in the Placebo group (-14.05%). Disease-free survival (DFS) was longer in the Nichi BRITE group (16.1 mo) compared to the Placebo group (12.4 mo), with a lower recurrence rate (50% versus 71.4%) for pancreatic cancers.

CONCLUSIONS

Administration of Nichi BRITE β-glucan during the perioperative period in patients undergoing surgery for pancreatic, bile duct and duodenal malignancies has been safe, and it has yielded immune enhancement and improvement in biomarkers of better prognosis. Reduction in circulating cancer stem cells and pancreatic cancer marker CA19-9 inclines us to recommend this Nichi BRITE β-glucan be included in onco-nutrition guidelines for patients undergoing surgical removal of malignant tumors.

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