Research paper
A Phase II Randomized Clinical Trial and Mechanistic Studies Using Improved Probiotics to Prevent Oral Mucositis Induced by Concurrent Radiotherapy and Chemotherapy in Nasopharyngeal Carcinoma
Study answer
What this study found
Probiotic cocktail significantly reduced OM severity during CCRT in NPC. OM grades 0–4: placebo 0/14.7/38.2/32.4/14.7% vs probiotic 13.9/36.1/25/22.2/2.8% (p<0.01). Grade 3–4 OM decreased from 47.1% (placebo) to 25% (probiotic); grade 4 OM from 14.7% to 2.8%. Immune measures showed smaller reductions in CD3+ T cells (75.5% vs 81%, p<0.01) and CD4+ T cells (64.53% vs 79.53%, p<0.01); CD8+ T cell reductions were 75.59% (probiotic) vs 62.36% (placebo) (p<0.01). Probiotic also modulated gut microbiota toward normal, increasing Firmicutes and decreasing Bacteroidetes/Actinobacteria. In rats,…
- Study & population
- Randomized, double-blind, placebo-controlled trial in male and female patients aged 18-70 with locally advanced nasopharyngeal cancer undergoing concurrent chemoradiotherapy (cisplatin + IMRT).
- Intervention
- Oral probiotic capsule mixture containing Lactobacillus plantarum MH-301 (10^9 CFU), Bifidobacterium animalis subsp.
- Key limitation
- Small, single-center trial; limited sample size; some dropouts; need for larger, diverse populations; fecal microbiota transplantation suggested to confirm microbiota involvement.
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Open PDFOriginal abstract
Earlier evidence has proven that probiotic supplements can reduce concurrent chemoradiotherapy (CCRT)-induced oral mucositis (OM) in nasopharyngeal cancer (NPC). The incidence of severe OM (grade 3 or higher) was the primary endpoint in this study. W…