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临床试验/NCT00584597
NCT00584597已完成1 期

The Safety and Efficacy of the Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Saline

干预措施: Saline (Drug)

2

Experimental

Traumeel S 1 mL

干预措施: Traumeel S (Drug)

3

Experimental

Traumeel S 2 mL

干预措施: Traumeel S (Drug)

4

Experimental

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

研究者

申办方类型
Other

研究点 (1)

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