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

NCT06285591 | Completed Phase 2

• 1 other identifier: 2023-1801
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Malignant Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The incidence of severe oral mucositis (SOM) (WHO grade ≥3)

  Oral mucositis is assessed by trained radiotherapists according to World Health Organization (WHO) oral toxicity Scale.The WHO Oral Toxicity Scale categorizes oral mucositis into grades 0-4, with the higher the grade the more severe the patient's oral mucositis. Grade 0 means that the oral mucosa is normal and the patient has no symptoms or signs; grade 1 means that the mucosa is erythematous with or without pain and does not interfere with eating; grade 2 means that the mucosa is erythematous and ulcerated, but still able to eat solid food; grade 3 means that the mucosa is severely ulcerated with extensive erythema and unable to eat solid food; and grade 4 means that the ulcers of the mucosa are fused together into a sheet, and their severity is so severe that it is not possible to eat.

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

Secondary Outcomes (5)

• The time to onset of severe oral mucositis (SOM) (WHO grade ≥3)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

• The duration of severe oral mucositis (WHO grade ≥3)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

• The incidence of oral mucositis (OM)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

• The time to onset of any-grade oral mucositis (OM)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

• The duration of any-grade oral mucositis (OM)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.

Other Outcomes (10)

• Quality of life as sssessed by the EORTC QLQ-C30 and QLQ-H&N35 Questionnaires

  1 week before radiotherapy ; at the middle of radiotherapy (usually 3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2, 3 months after the end of radiotherapy.

• Mouth and throat soreness score

  The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.

• Hyposalivation

  1 week before radiotherapy ; at the middle of radiotherapy (usually 3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3 months after the end of radiotherapy.

Study Arms (2)

Control group

PLACEBO COMPARATOR

Placebo-containing tablets

Drug: Placebo-containing tablets; Radiation: Radiotherapy

Experimental group

EXPERIMENTAL

Lactobacillus reuteri tablets

Drug: Lactobacillus reuteri Tablets; Radiation: Radiotherapy

Interventions

Lactobacillus reuteri Tablets DRUG

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

Experimental group

Placebo-containing tablets 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.

Control group

Radiotherapy 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.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
• Aged 18-80 years;
• Eastern Cooperative Oncology Group performance status of ≤2;
• Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
• Sign informed consent.

You may not qualify if:

• Patients with known allergy to probiotic or severe allergic constitution;
• Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
• Poor oral hygiene and/or severe periodontal diseases;
• History of head and neck radiotherapy;
• Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xingchen Peng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 29, 2024
• Study Start: March 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)