Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy

Sichuan University

Status and phase: Completed; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: Streptococcus salivarius K12 simulants; Drug: Streptococcus salivarius K12

Study type: Interventional

Funder types: Other

Identifiers

NCT05918224

ChiCTR2100054689

Details and patient eligibility

About

To evaluate the efficacy and safety of Streptococcus salivarius K12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.

Full description

The goal of this clinical trial is to evaluate the efficacy and safety of Streptococcus salivarius K12 in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Streptococcus salivarius K12 can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy.

Participants will be instructed to suck a Streptococcus salivarius K12 or placebo lozenge three times daily from the beginning to the end of RT. After using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour.

Researchers will compare Streptococcus salivarius K12 group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.

Enrollment: 160 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with non-metastatic head and neck malignant tumor diagnosed by histopathology;
• Aged 18 to 80 years;
• Systemic functional status Eastern Cooperative Oncology Group (ECOG) (Appendix 1) rating ≤2;
• Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
• Sign the informed consent

Exclusion criteria

• Patients with known allergy to probiotic or severe allergic constitution;
• Using antibiotics/antifungal drugs within 1 month or using antimicrobial mouthwash within 1 week before the study;
• Poor oral hygiene and/or severe periodontal diseases;
• Any previous RT to the head and neck region;
• Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

S. salivarius K12 group: The S. salivarius K12 lozenges (NOW Foods, USA) contained not less than 1×109 CFU viable cells of S. salivarius K12 as the active ingredient. The S. salivarius K12 lozenges were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day).

Treatment:

Drug: Streptococcus salivarius K12

Placebo group

Placebo Comparator group

Description:

Placebo group: Placebo lozenges contained sugar and starch used as excipients in the active formulation. The placebo lozenge were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day).

Treatment:

Drug: Streptococcus salivarius K12 simulants