Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With Head and Neck Cancer: Randomized Clinical Study

Background: The side effects of antineoplastic therapies of the head and neck aggravate the condition of patients resulting in a decrease in the quality of life. At oral level, they can induce the appearance of certain alterations, this predisposes to an imbalance in the oral microbiota, increasing the presence of acidogenic and cariogenic bacteria. In the oral cavity probiotics are associated with a decrease in the colony forming unit (CFU) count of cariogenic pathogens and inhibition of periodontal pathogens. In addition, they modulate the inflammatory response (humoral and cellular). For this reason, they could be considered a good alternative to modulate the oral microbiota in head and neck oncology patients. Hypothesis: The use of probiotics due to the change of the oral microbiota is associated with a beneficial effect against oral complications produced by radiotherapy, chemotherapy and surgery in patients with head and neck cancer, so that probiotic users will have a greater reduction in oral complications induced by cancer therapies compared to those who do not use probiotics. Objectives: To evaluate the effects of probiotics on oral complications induced by antineoplastic therapies in patients with head and neck cancer, attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and the Dental Hospital of the University of Barcelona (HOUB), Faculty of Medicine and Health Sciences Bellvitge campus during the period 2022- 2024. Methodology: Randomized Clinical Trial during the period 2022-2024. The identification of the population of interest will be patients attended in the radiotherapy service at the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), in the Master of Dentistry and in Oncology and Immunocompromised Patients. Data will be collected by electronic record, clinical examination, microbiological and radiographic analysis of the participants. Expected results: The use of probiotics is expected to provide a greater reduction in oral complications induced by head and neck antineoplastic therapies. Statistical analysis: Comparison of categorical variables chi-square test, numerical variables Student's test for independent samples and paired samples or Mann-Whitney U test and Wilcoxon signed-rank test. Relative risk with 95% confidence interval. An intention-to-treat analysis will be performed.