Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Side effects after radiotherapy
研究概览
简要总结
The aim of the study is to demonstrate in a clinical condition the effectiveness of a preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting cancer patients in minimizing side effects after a radiation therapy cycle.
详细描述
The study will be conducted on a group of 10 patients with head and neck cancer who have undergone radiation therapy and experience side effects such as discomfort/changes in the oral mucosa.The patients will receive an aerosol for oral use for a period of 1 month. Before and after the study, an assessment questionnaire related to the side effects of radiation therapy will be conducted, along with the MD Anderson Dysphagia Inventory questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men, 18-75 years old
- •Patients with head and neck cancer or other types of cancer after radiotherapy who suffer from oral mucositis
- •Patients with dryness in mouth
- •Signed informed consent.
排除标准
- •Intake of supplements containing plant extracts, polyphenols or anthocyanins
- •Participation in another clinical trial,
- •Women who are pregnant, planning to become pregnant during the study or breastfeeding,
- •Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation.
- •Hypersensitivity/allergy to any of the ingredient
结局指标
主要结局
Side effects after radiotherapy
时间窗: Baseline, 1 month
Based on a questionnaire
次要结局
- Impact of dysphagia on quality of life(Baseline, 1 month)