Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors

NCT ID: NCT06285591

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-01-01

Brief Summary

To evaluate the efficacy and safety of Lactobacillus reuteri 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 Lactobacillus reuteri in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Lactobacillus reuteri 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 Lactobacillus reuteri or placebo lozenge twice 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 Lactobacillus reuteri 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 Malignant Tumors

Keywords

Head and Neck Malignant Tumors; Radiation-induced oral mucositis; Lactobacillus reuteri

Study Design

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

Study Groups

Control group

Placebo-containing tablets

Group Type: PLACEBO_COMPARATOR

Placebo-containing tablets

Intervention Type: DRUG

The placebo lozenges shared the same formulation as the L. reuteri lozenges but without the probiotic, whose appearance, taste, and color were identical to those of the Lactobacillus reuteri lozenges.

Radiotherapy

Intervention Type: RADIATION

One of the inclusion criteria for the study was that patients with malignant tumors of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.

Experimental group

Lactobacillus reuteri tablets

Group Type: EXPERIMENTAL

Lactobacillus reuteri Tablets

Intervention Type: DRUG

Lactobacillus reuteri lozenges (NOW Foods, Sweden) contained 2×10\^8 CFU viable cells of Lactobacillus reuteri as the active ingredient.

Radiotherapy

Intervention Type: RADIATION

One of the inclusion criteria for the study was that patients with malignant tumors of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.

Interventions

Lactobacillus reuteri Tablets

Lactobacillus reuteri lozenges (NOW Foods, Sweden) contained 2×10\^8 CFU viable cells of Lactobacillus reuteri as the active ingredient.

Intervention Type: DRUG

Placebo-containing tablets

The placebo lozenges shared the same formulation as the L. reuteri lozenges but without the probiotic, whose appearance, taste, and color were identical to those of the Lactobacillus reuteri lozenges.

Intervention Type: DRUG

Radiotherapy

One of the inclusion criteria for the study was that patients with malignant tumors of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;

2. Aged 18-80 years;

3. Eastern Cooperative Oncology Group performance status of ≤2;

4. Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;

5. Sign informed consent.

Exclusion Criteria

1. Patients with known allergy to probiotic or severe allergic constitution;

2. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;

3. Poor oral hygiene and/or severe periodontal diseases;

4. History of head and neck radiotherapy;

5. 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

2023-1801

Identifier Type: -

Identifier Source: org_study_id