Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The incidence of severe oral mucositis (SOM) (WHO grade ≥3)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Control group
Placebo-containing tablets
干预措施: Placebo-containing tablets (Drug)
Control group
Placebo-containing tablets
干预措施: Radiotherapy (Radiation)
Experimental group
Lactobacillus reuteri tablets
干预措施: Lactobacillus reuteri Tablets (Drug)
Experimental group
Lactobacillus reuteri tablets
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
The incidence of severe oral mucositis (SOM) (WHO grade ≥3)
时间窗: 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.
次要结局
- 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.)
研究者
Xingchen Peng
PhD, Professor
West China Hospital