Prevention and Improvement for Oral Mucositis Care During Chemoradiotherapy in Head and Neck Cancer Patients With Honey Production
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- oral mucositis severity
研究概览
简要总结
Oral mucositis is common among cancer patients receiving radiotherapy and chemotherapy. 80-90% of the patients are suffering from the mucositis pain; poor nutrition and even treatment discontinued. Some self-paid medications like glutamine has been used to prevent mucositis before and during radiotherapy/chemotherapy. Randomized controlled trials have shown that honey and propolis may be used for the management of mucositis. Honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. This study plan to conduct an RCT comparing the effectiveness of honey, honey and green propolis, and usual care in mucositis of cancer patients.
详细描述
Outcome Measures
- Questionnaire collection: oral mucositis grade, pain scale, fatigue scale, dry mouth, nutritional status and quality of life scale.
- Wearing the smart bracelet: The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status.
- Saliva sample collection: Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva.
- Stool and oral flora collection: Test stool and oral flora microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with a head and neck tumor.
- •receive chemotherapy or radiotherapy.
- •conscious clear and willing to participate in the research.
- •can communicate in Mandarin or Taiwanese.
排除标准
- •diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.
结局指标
主要结局
oral mucositis severity
时间窗: up to 12 weeks
Ulceration or inflammation of the oral mucosa characterizes oral Mucositis
次要结局
- fatigue level(up to 12 weeks)
- nutrition level(up to 12 weeks)
- Saliva specimen collection(This saliva is collected Baseline (before the start of radiotherapy), week 1, week 2, week 3, and up to 12 weeks)
- pain score(up to 12 weeks)
- Xerostomia score(up to 12 weeks)
- QoL questionnaire(up to 12 weeks)
- microbiota level(Baseline (Before the start of radiotherapy), week 2, week 4, and up to 12 weeks)
- smart bracelet data(The first week, the fourth week, the 8th week start wearing the smart bracelet for 7 days)