DRKS00015229已完成不适用
Pilot study evaluating changes in the oral mucosa using optical coherence tomography as part of radio(chemo)therapy in patients with head and neck cancer - OCT
niversitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie0 个研究点目标入组 1 人开始时间: 2019年12月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
Due to the COVID-19 pandemic, recruitment was initially interrupted and then not reactivated due to a lack of recruitment. An evaluation was not possible due to insufficient patient numbers.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age =18 years; good general condition according to WHO grade 0-1; patients with oropharyngeal carcinoma + oral cavity; primary / postoperative radiotherapy or chemoradiotherapy with cisplatin +/- 5-FU; with a total oral dose of =40 Gy; prescribed total dose (GD) in primary radiotherapy (RTx) / chemoradiotherapy (RCTx) = 70 Gy; prescribed GD at adjuvant RTx / RTCx = 60 Gy; adequate mouth opening; Trism = grade I; preserved anterior teeth after dental restoration (fixed implants or bridges are permitted); signed declaration of consent
排除标准
- •Pre-irradiation with significant load (> 10 Gy) of the oral cavity; expected lack of compliance; missing anterior teeth/removable prosthesis for anterior teeth; Trismus > Grade I (restricted mouth opening); participation in an intervention study with drug application or modification of the radio(chemo)therapy regimen 4 weeks before or during radiotherapy
研究者
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