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

Sichuan University

Status and phase: Completed; Phase 2

Conditions: Head and Neck Malignant Tumors

Treatments: Drug: Placebo-containing tablets; Drug: Lactobacillus reuteri Tablets; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06285591

2023-1801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

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

Control group

Placebo Comparator group

Description:

Placebo-containing tablets

Treatment:

Radiation: Radiotherapy

Drug: Placebo-containing tablets

Experimental group

Experimental group

Description:

Lactobacillus reuteri tablets

Treatment:

Radiation: Radiotherapy

Drug: Lactobacillus reuteri Tablets