EUCTR2014-004349-29-DK进行中（未招募）1 期
Mesenchymal stem cells for radiation-induced xerostomia (MESRIX) in previous HPV-positive oropharyngeal head and neck cancer patients - MESRIX
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 HPV-positive oropharyngeal head and neck cancer with bilateral irradiation of the neck.
- •2 years follow-up without recurrence
- •Clinically reduced hyposalivation and hyposalivation, evaluated by a screening
- •oUnstimulated salivary flow rate between less than 0.2ml/min and above 0.05ml/min
- •Only participants with previous T1-T2 and N0, N1 or N2a.
- •Informed consent
- •Grade 1-43 xerostomia as evaluated by the UKU side effect rating scale
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any cancer in the previous 2 years
- •Xerogenic medications
- •Any previous other diseases in of the salivary glands, e.g. Sjögrens syndrome, sialolithiasis, etc.
- •Pregnancy or planned pregnancy within the next 2 years
- •Breastfeeding
- •Any other disease/condition judged by the investigator to be grounds for exclusion
- •Treatment with anticoagulant that cannot be stopped during the intervention period.
研究者
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