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Completed

NCT Number: NCT06285591

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

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.

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Key information

Conditions

Head and Neck Malignant Tumors

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Lactobacillus reuteri Tablets

Drug

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

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.

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.

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    Time from the first day of radiotherapy to the first determination of SOM.

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

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

    The first determination of SOM to the first instance of non-severe OM (WHO grade <3), without a subsequent instance of SOM.

  3. The incidence of oral mucositis (OM)

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

    Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.

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

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

    Time from the first day of radiotherapy to the first determination of OM.

  5. The duration of any-grade oral mucositis (OM)

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

    The first determination of OM to the first instance of non-OM, without a subsequent instance of OM.

Other outcomes

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

    Time frame: 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.

    European Organization for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Head and Neck Cancer Module (EORTC QLQ-H&N35).

  2. Mouth and throat soreness score

    Time frame: 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.

    Patients report two scores via the Oral Mucositis Weekly Questionnaire (OMWQ): (1) the severity of mouth and throat soreness (MTS) and (2) the degree of its impact on oral activities (including swallowing, drinking, eating, talking, and sleeping). Both items use a Likert scale from 1 to 5, with higher scores indicating more severe symptoms or greater functional impairment.

  3. Hyposalivation

    Time frame: 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.

    Hyposalivation was graded per CTCAE v5.0 (Grade 1-4), with higher grades indicating worse symptoms.

  4. Gustatory function

    Time frame: 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.

    Taste strips test.

  5. Change in weight

    Time frame: 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.

    The change in patient's body weight measured at baseline (pre-radiotherapy) and at the end of radiotherapy.

  6. The number of patients receiving parenteral nutrition

    Time frame: 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.

    This outcome records the number of patients who receive parenteral nutrition from the start to the completion of radiotherapy.

  7. The number of patients receiving analgesics

    Time frame: 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.

    This outcome records the number of patients who receive analgesics from the start to the completion of radiotherapy.

  8. Radiotherapy interruption rate

    Time frame: 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.

    The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.

  9. Adverse events

    Time frame: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.

    Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version

  10. The composition and dynamics of salivary microbiota

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

    Unstimulated whole saliva samples will be collected via spitting method at three time points: baseline, mid-term radiotherapy (the week corresponding to 50% completion of the planned radiation fractions), and the end of radiotherapy (the final week of RT). 16S rRNA gene sequencing will be performed to assess alterations in the oral microbiota.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.