Clinical Question: Can an oral probiotic lozenge containing Streptococcus salivarius K12 minimize radiation-induced mucositis?
Background: Patients with head and neck cancer are often treated with radiation therapy, and more than half of these patients develop oral mucositis as a common sequela. Oral mucositis can significantly impair quality of life through localized pain, dysphagia, and dysarthria. Optimizing a patient’s oral microbiome may reduce both the incidence of and severity of mucositis.
Study Design: Prospective, randomized, double-blinded, placebo-controlled trial
Setting: Single, tertiary care, academic, medical center in China
Synopsis: Streptococcus salivarius K12 (SsK12) can enhance the oral microbiome by decreasing anaerobic pathogens. This trial compared lozenges containing at least 1 x 109 colony-forming units of viable SsK12 cells to placebo for the prevention of radiation-induced oral mucositis. Eligible patients had head and neck cancers with no evidence of metastases, good functional capacity (Eastern Cooperative Oncology Group scale of up to 2), age of 18 to 80, no significant dental hygiene issues, no prior head or neck radiation treatment, no antimicrobial therapy within the past month, and no use of antimicrobial mouthwash within the past week. A total of 160 patients were randomized one-to-one (80 per arm), with an eventual 72 patients in the control group and 71 patients in the test group. Participants dissolved the lozenges in their mouths three times daily. All participants abstained from eating or drinking for one hour afterwards. SsK12 lozenges significantly decreased the incidence and duration of severe oral mucositis and also delayed its onset. The test group had numerically lower rates of both analgesic use and IV fluids or total parenteral nutrition. Saliva samples from the Ssk12 group demonstrated a more favorable oral microbiome profile. The SsK12 lozenges had mild gastrointestinal side events, but there were no severe adverse reactions in either arm.
Bottom Line: Oral lozenges containing Streptococcus salivarius K12 minimize radiation-induced oral mucositis by optimizing the patient’s oral microbiota.
Citation: Peng X, et al. Streptococcus salivarius K12 alleviates oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors: a randomized controlled trial. J Clin Oncol. 2024;42(12):1426-1435. doi:10.1200/JCO.23.00837.
Dr. Ally
Dr. Ally is a clinical professor of medicine in the division of hospital medicine and a physician advisor at UC San Diego in San Diego.