Comparison of Triamcinolone Acetonide Mucoadhesive Film With Liquorice Mucoadhesive Film On Radiotherapy-Induced Oral Mucositis: A Randomized Double-Blinded Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
Abstract:
Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief, correction of nutritional status and improving the performance status. However, lack of standardization is the major obstacle for any scientific evaluation of any CAM trial. Mucositis is a major complication of irradiation in head and neck (H&N) tumors, the addition of chemotherapy to irradiation may enhance this dose limiting problem. Licorice is a strong demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of this study was to compare the therapeutic safety and efficacy of T. and L. mucoadhesive films on oral mucositis in terms of pain control and/or ulcer treatment.
Methods and Materials: the study was a double-blind, randomized prospective trial of two types of mucoadhesive films in the management of oral mucositis occurred during head and neck cancer ( HNC ) radiotherapy. oral mucositis was assessed using a quantitative scale (WHO scales) and symptoms were assessed using visual analogue scales (VAS). 60 patients were enrolled in the study; there were 30 patients in the Triamcinolone (T) and 30 in the Licorice (L) group. In the T- group, patients received triamcinolone acetonide mucoadhesive films containing 1mg of the drug and patients in the L- group received licorice mucoadhesive films, an herbal agent. Data were collected at baseline, then twice a week for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •over 18 years of age
- •men and nonpregnant women
- •women of childbearing age who were non-pregnant by pregnancy test and and using medically prescribed contraceptive
- •no previous radiation therapy applied in the head and neck
- •medically fit for a course of radical radiotherapy
- •an ability to remain in the study for its entire duration
排除标准
- •pregnant women
- •women of childbearing potential in whom medically prescribed birth control was not used
- •concurrent chemotherapy
- •history of heavy alcohol or drug abuse judged to be important by the investigator - concomitant therapy with an investigational drug, or cancer chemo therapeutics or immunosuppressive medications
- •sensitivity or intolerance to triamcinolone or licorice, lactose or similar formulations
- •inability to provide informed consent
- •actively bleeding gastric ulcer, severe esophageal reflux
- •major surgery, trauma or burns in the preceding 4 weeks
- •clinically significant hepatic, neurologic, endocrine, or other systemic disease-making implementation of the protocol or results difficult.
研究组 & 干预措施
triamcinolone acetonide mucoadhesive
30 patients received triamcinolone acetonide mucoadhesive films
干预措施: Triamcinolone Acetonide (Drug)
Licorice
30 patients received licorice mucoadhesive films
干预措施: licorice mucoadhesive films (Drug)
结局指标
主要结局
pain score
时间窗: 4 weeks
at the end of each consecutive week the pain score was recorded.
次要结局
- mucositis grade(4 weeks)
研究者
Mehdi Nasr Isfahani
Dr. Nasr
Isfahan University of Medical Sciences