CompletedPhase 2

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

China160 participantsStarted 2024-03-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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).

What they're measuring

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

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

Trial details

NCT IDNCT06285591

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Head and Neck Malignant Tumors trials