A Pilot Trial to Assess the Effects of Green Tea in the Prevention of Therapy-Induced Mucositis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Assess the effect of tea on reducing the incidence or severity of chemotherapy induced mucositis
研究概览
简要总结
This is a clinical research study that is designed to determine if there is a potential benefit of green tea to help treat and prevent therapy induced mucositis, which is mouth sores caused by chemotherapy.
详细描述
The overall objective of this study is to assess the effect of green tea on reducing the incidence or severity of chemotherapy (with or without radiotherapy) induced mucositis in patients receiving standard therapy that will produce a very high likelihood of oral, esophageal, or gastrointestinal mucositis (e.g. high dose chemotherapy with stem cell reconstitution in patients with multiple myeloma; concurrent 5-FU/ cisplatin and radiotherapy to the head and neck area; patients receiving paclitaxel).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of cancer for which standard chemotherapy will produce a very high likelihood of oral, esophageal or gastrointestinal mucositis (e.g. high dose chemotherapy with stem cell reconstitution in patients with multiple myeloma; concurrent 5-FU/ cisplatin and radiotherapy to the head and neck area; patients receiving paclitaxel). Patients receiving concurrent chemotherapy/radiation therapy for lung or gastrointestinal cancer are eligible.
- •If not receiving a highly mucosally toxic regimen, have had Grade 2 mucositis on the prior cycle of chemotherapy Have no evidence of active infection in the oral cavity such as thrush, HSV, or aphthous ulcers.
- •Patients must be free of known infectious stomatitis or systemic infection (culture not required). If unclear that the patient has infectious stomatitis, cultures may be obtained and the patient entered on study.
- •Must be free of Grade 3 or 4 vomiting. Have no contraindication for buccal scrapings. Not be a frequent (>3 cups per day) tea drinker Must be able to speak English.
排除标准
- •Xerostomia Use of any investigational agent (not FDA approved) Current use of, allopurinol, prostaglandin inhibitors, sulcralfate, vitamin E or antioxidant supplements during the course of this study.
- •Patients receiving an anesthetic "cocktail" regimen or other topical anesthetics.
- •Patients with existing oral lesions.
结局指标
主要结局
Assess the effect of tea on reducing the incidence or severity of chemotherapy induced mucositis
次要结局
- Correlate the levels of tea polyphenols in buccal cells and in saliva with the effect of tea on the change in incidence or severity of treatment induced mucositis.
- Correlate the analyses of proliferation index, cyclooxygenase, and prostagladin E- 2 with the change in incidence or severity of chemotherapy induced mucositis.