Effect of a fermented dairy beverage on radiation-related gastrointestinal toxicity and inflammation in locally advanced cervical cancer patients, a randomized placebo-controlled pilot study

Background: Locally advanced cervical cancer (LACC) is a health burden in low- and middle-income countries. Treatment with chemoradiotherapy (CRT) causes intestinal inflammation and toxicity that affects the nutritional status and quality of life of patients. This study aimed to analyze the effect of a probiotic-rich fermented dairy beverage, compared to a placebo, on gastrointestinal toxicity, inflammatory response, chronic toxicity and quality of life in LACC patients. Methods: A randomized, double-blind, placebo-controlled pilot study assigned LACC patients to the probiotic group (n = 21) or the placebo group (n = 21). Intervention with probiotic or placebo beverages began two weeks before treatment and continued 90 days after treatment. The frequency and severity of toxicity symptoms, nutritional parameters, serum cytokines, fecal calprotectin, proctopathy, and quality of life were evaluated throughout treatment. Results: Lower frequency and severity of nausea and vomiting were observed in the probiotic group compared to placebo (15% vs. 40%). No differences among groups were observed in the frequency of other symptoms, including diarrhea. A trend was shown toward lower levels of inflammatory cytokines in the probiotic group. No significant differences were observed in the development of proctopathy. Conclusions: This study demonstrated the fermented dairy beverage’s beneficial effect on reducing the frequency and severity of vomiting and a tendency to lower inflammation. Still, it did not provide benefits regarding other treatment-related toxicities, including diarrhea, probably due to the small sample size. Clinical Trial Registration: The Trial Registration Number is NCT05736315.

Fermented dairy beverage; Probiotic; Lactobacillus casei Shirota; Gastrointestinal inflammation; Locally advanced cervical cancer; Chemoradiotherapy toxicity

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