EUCTR2018-000348-24-DK进行中（未招募）1 期
Mesenchymal stem cells for radiation-induced hyposalivation and xerostomia in previous head and neck cancer patients (MESRIX-II) - MESRIX_III
Department of Otorhinolaryngology, Head and Neck Surgery0 个研究点目标入组 120 人开始时间: 2018年3月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Previous radiotherapy for head and neck cancer
- •2 years follow-up without recurrence
- •Clinically hyposalivation: unstimulated salivary flow < 0.2ml /ml and above 0.05 ml/min
- •Informed consent
- •Grade 1-3 Xerostomia evaluated by the UKU side effect rating scale
- •WHO performance score 0-1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Any cancer in the previous 2 years ( not including OPSCC and basocellular carcinoma)
- •Smoking within the last 6 months
- •Xerogenic medications within the last 3 months
- •Any current or previous other diseases in the salivary glands (Sjögrens syndrome, Sialolithiasis etc.)
- •Pregnancy or planned pregnancy with the next 2 years
- •Breastfeeding
- •Any other disease/condition juged by the investigator to be grounds for exclusion
研究者
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