A phase II randomized controlled trial of orally administered yeast-derived β-glucan for alleviating chemoradiotherapy-induced oral mucositis in nasopharyngeal carcinoma patients

Background Patients with locoregionally advanced nasopharyngeal carcinoma (NPC) undergoing chemoradiotherapy frequently experience severe oral mucositis, with incidence rates ranging from 78.6%-88%. This adverse effect often disrupts therapeutic adherence and negatively impacts nutritional intake. This Phase II trial evaluated oral yeast-derived β-glucan (PGG) for alleviating mucositis and improving nutrition in NPC patients. Methods Sixty-three stage III-IVa NPC patients receiving radical radiotherapy (70 Gy/33F) with concurrent cisplatin were randomized to PGG supplementation (Experimental group, 5 g/10kg/day, n=30) plus routine care or routine care alone (Control group, n=30). Mucositis severity (RTOG criteria), nutritional parameters (PG-SGA, body composition), and hematological indices were assessed weekly. Results The experimental Group showed significantly reduced mucositis severity: 70% achieved grade 0-I (vs. 36.7% controls; U = 266.000, p=0.004), with grade III incidence at 6.67% (vs. 26.67%). Nutritional outcomes improved in the experimental Group, evidenced by lower PG-SGA scores at week 4 (10.93 ± 2.60 vs. 12.37 ± 2.39, p=0.03), attenuated weight loss during weeks 3-4 (p0.05), and increased body fat percentage (p0.05). No intergroup differences occurred in pain scores, muscle mass, or hematological parameters (leukocytes, hemoglobin, platelets, lymphocyte subsets). Conclusion Oral PGG significantly reduces severe mucositis incidence and mitigates nutritional deterioration during NPC chemoradiotherapy without added toxicity.