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

Plain-language summary

This study examined whether Lactobacillus reuteri tablets, compared with placebo, help relieve oral mucositis (inflammation in the mouth) in patients receiving radiotherapy for head and neck cancer. It enrolled patients aged 18-80 with non-metastatic head and neck cancer receiving definitive or post-operative radiotherapy. The study was in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

West China Hospital

Intervention

Lactobacillus reuteri Tablets, Placebo-containing tablets, Radiotherapy

Start date

3/1/2024

Estimated completion

1/1/2025

Countries

China

Related genes

Locations

• Chengdu, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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).