The Safety and Efficacy of the Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The specific aim will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy
研究概览
简要总结
The specific aim of this study will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy.
详细描述
Oral mucositis is a debilitating side effect of radiation therapy for head and neck cancer patients. The severe inflammation of the oral cavity can be detrimental to quality of life and cause interruption in vital cancer treatment. Despite numerous proposed therapies, an effective agent for oral mucositis has yet to be found. TRAUMEEL S, a homeopathic remedy made up of highly diluted botanical extracts and minerals, has shown benefit for mucositis in children undergoing chemotherapy. The objective of this study is to evaluate the safety of TRAUMMEL S in the prevention and treatment of radiation-induced oral mucositis. The patients will use the medication as a mouthwash during radiation therapy and will be evaluated weekly with physical examination criteria and questionnaires for symptoms and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Head and neck cancer patients post resection of primary tumor with negative or microscopically positive surgical margins
- •Patients undergoing planned radiation therapy
- •Age 18 to 99
- •Nonsmokers
排除标准
- •Head and neck cancer patients post resection of primary tumor with grossly positive surgical margins
- •Patients receiving adjuvant chemotherapy
- •Pediatric patients (age < 18)
- •Pregnant women
研究组 & 干预措施
1
Saline
干预措施: Saline (Drug)
2
Traumeel S 1 mL
干预措施: Traumeel S (Drug)
3
Traumeel S 2 mL
干预措施: Traumeel S (Drug)
4
Traumeel S 3 mL
干预措施: Traumeel S (Drug)
结局指标
主要结局
The specific aim will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy
时间窗: 4 years
次要结局
未报告次要终点
