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

NCT ID: NCT05918224

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-11-30

Brief Summary

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.

Detailed 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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group

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).

Group Type: EXPERIMENTAL

Streptococcus salivarius K12

Intervention Type: DRUG

The patients in intervention group were treated with Streptococcus salivarius K12 lozenges three times a day after gargling from the first day of radiotherapy up to 1 week after the end of treatment. Streptococcus salivarius K12 is dissolved in the mouth and then swallowed.

Placebo group

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).

Group Type: PLACEBO_COMPARATOR

Streptococcus salivarius K12 simulants

Intervention Type: DRUG

Patients in control group were treated with Streptococcus salivarius K12 simulants, and its use method and use time are the same as intervention group.

Interventions

Streptococcus salivarius K12

The patients in intervention group were treated with Streptococcus salivarius K12 lozenges three times a day after gargling from the first day of radiotherapy up to 1 week after the end of treatment. Streptococcus salivarius K12 is dissolved in the mouth and then swallowed.

Intervention Type: DRUG

Streptococcus salivarius K12 simulants

Patients in control group were treated with Streptococcus salivarius K12 simulants, and its use method and use time are the same as intervention group.

Intervention Type: DRUG

Other Intervention Names

OralBiotic BLIS K12 (NOW Foods, USA)

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xingchen Peng

PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingchen Peng

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

ChiCTR2100054689

Identifier Type: -

Identifier Source: org_study_id