Phase 2 Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups
研究概览
简要总结
The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •diagnosis of head and neck cancer
- •planned treatment course to include Cisplatin and radiation therapy, cumulative prescription dose between 50-70 Gy
- •able to eat at least soft solids
- •normal cardiac function
- •able to perform oral rinse
排除标准
- •Induction chemotherapy regimen
- •life threatening allergic reaction to food and/or drugs
- •history of any other primary malignancy diagnosed within the past 5 years
- •prior radiation to the sites to be treated
- •active infections of the oral cavity
研究组 & 干预措施
Active oral rinse
Oral rinse containing botanical extracts
干预措施: IZN-6N4 (Drug)
Placebo rinse
干预措施: IZN-6N4 (Drug)
结局指标
主要结局
Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups
时间窗: Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks.
Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial
次要结局
- Incidence of grade 2-3-4 Oral Mucositis as measured by the WHO scale at increasing increments of cumulative radiation exposure(Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks.)