Phase II Study of Dentoxol® Mouthrinse for Oral Mucositis Secondary to Radiation Therapy for Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 3
- 主要终点
- Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale
研究概览
简要总结
The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to 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
- •Planned to receive radiation therapy for cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx, with or without concomitant chemotherapy.
- •Planned to receive at least 5000cGy radiation therapy to at least 2 of 12 pre-specified areas in the oral cavity
排除标准
- •Unable to give written informed consent
- •Known allergy/intolerance to any component of the study rinse or placebo
- •Planning to use any contraindicated medications during the study period (pain medications are allowed)
- •Age below 18 years
- •Pregnant or nursing (If the patient is a woman of childbearing potential, a pregnancy test must be performed within fourteen days before enrollment in the study)
研究组 & 干预措施
Dentoxol
Dentoxol® is a proprietary mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. Subjects will use Dentoxol® mouthrinse 5 times each day, starting on the first day of radiation therapy and ending on the last day of radiation therapy.
干预措施: Dentoxol (Device)
Placebo
The placebo rinse will be identical in color, taste and consistency as the Dentoxol rinse and will be packaged in identical bottles with the same labels. Subjects will use placebo mouthrinse 5 times each day, starting on the first day of radiation therapy and ending on the last day of radiation therapy.
干预措施: Placebo (Device)
结局指标
主要结局
Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale
时间窗: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
次要结局
- Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale.(First day of radiation therapy through last day of radiation therapy (5-8 weeks))
- Mouth pain scores, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).(First day of radiation therapy through last day of radiation therapy (5-8 weeks))
- Ability to eat, drink, and swallow, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).(First day of radiation therapy through last day of radiation therapy (5-8 weeks))
- Weight loss, as measured by the difference between weight on first and last day of radiation therapy.(First day of radiation therapy through last day of radiation therapy (5-8 weeks))
- Use of opioid analgesics for oral mucositis pain, as expressed in morphine equivalents.(First day of radiation therapy through last day of radiation therapy (5-8 weeks))