Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy for Head and Neck Tumor: A Randomized, Placebo-Controlled, Double-Blind 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 (WHO grade ≥3)
研究概览
简要总结
To evaluate the efficacy and safety of Streptococcus salivarius K12 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 Streptococcus salivarius K12 in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Streptococcus salivarius K12 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 Streptococcus salivarius K12 or placebo lozenge three times 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 Streptococcus salivarius K12 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 with non-metastatic head and neck malignant tumor diagnosed by histopathology;
- •Aged 18 to 80 years;
- •Systemic functional status Eastern Cooperative Oncology Group (ECOG) (Appendix 1) rating ≤2;
- •Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
- •Sign the informed consent
排除标准
- •Patients with known allergy to probiotic or severe allergic constitution;
- •Using antibiotics/antifungal drugs within 1 month or using antimicrobial mouthwash within 1 week before the study;
- •Poor oral hygiene and/or severe periodontal diseases;
- •Any previous RT to the head and neck region;
- •Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
研究组 & 干预措施
Experimental group
S. salivarius K12 group: The S. salivarius K12 lozenges (NOW Foods, USA) contained not less than 1×109 CFU viable cells of S. salivarius K12 as the active ingredient. The S. salivarius K12 lozenges were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day).
干预措施: Streptococcus salivarius K12 (Drug)
Placebo group
Placebo group: Placebo lozenges contained sugar and starch used as excipients in the active formulation. The placebo lozenge were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day).
干预措施: Streptococcus salivarius K12 simulants (Drug)
结局指标
主要结局
The incidence of Severe Oral mucositis (WHO grade ≥3)
时间窗: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.
次要结局
- Adverse events(From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks)
- Taste function(1 week before radiotherapy ; at the middle of radiotherapy (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, 6, 9 and 12 months after the end of radiotherapy)
- functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire.(1 week before radiotherapy; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); ; and 1, 3, 6, 9 and 12 months after the end of radiotherapy)
- The number of patients who missed five or more consecutive radiation fractions.(The time period is the period from the start of radiotherapy to the completion of radiotherapy)
- Xerostomia(1 week before radiotherapy ; at the middle of radiotherapy (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, 6, 9 and 12 months after the end of radiotherapy)
- Oral activities scores(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 1/2 weeks)
- The duration of Severe Oral mucositis (WHO grade ≥3)(From the start of radiotherapy to 8 weeks after completion of radiotherapy)
- Mouth and throat soreness (MTS) scores(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 1/2 weeks)
- The time to onset of Severe Oral mucositis (WHO grade ≥3)(From the start of radiotherapy to 8 weeks after completion of radiotherapy)
研究者
Xingchen Peng
PhD, Professor
West China Hospital