Live Laser Microscopic Evaluation (OCT) of Radiation Induced Preclinical Alterations of the Skin in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- early radiation induced skin structure changes detected in OCT
研究概览
简要总结
The purpose of this study is to determine whether any eventual skin damage caused by radiation therapy can be detected and monitored at a subclinical level via optical coherence tomography (OCT). Another key question is whether subclinical OCT detected skin damage correlates with acute and late clinical toxicity.
详细描述
Head and neck cancer patients that meet the eligibility criteria and singned the informed consent will undergo OCT-measurements before, during and after the course of radiation therapy. At the same time-points the skin areas are evaluated with dermatoscopy and patients are asked to self-assess their quality of life (EORTC QLQ C30 and respective head and neck module H&N 43).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cancer located at: nasopharynx, oropharynx, hypopharynx, larynx, oral cavity and definitive or adjuvant radiation- or radio-chemotherapy
排除标准
- •reduced mental capacity
- •treatment with C225 Cetuximab
- •bearded patients
- •overt skin disease
- •vast tattoos in the neck region
研究组 & 干预措施
Head and Neck Cancer Patients
Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer
干预措施: OCT (Device)
Head and Neck Cancer Patients
Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer
干预措施: Dermatoscope (Device)
结局指标
主要结局
early radiation induced skin structure changes detected in OCT
时间窗: First week of radiation therapy
any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)
次要结局
- detection of any skin strucure changes with OCT during the course of RT(weeks 1 - 6 of radiation therapy)
- Correlation of OCT changes with clinical appearent acute side effetcs(weeks 1 - 6 of radiation therapy)
- Correlation of OCT changes with dermatoscopic skin appearance(weeks 1-6 of RT)
- Correlation of OCT changes with clinical appearent late side effetcs(1 year post-RT)
- Correlation of quality of live with OCT and radiation sensitivity(weeks 1-6 of RT, 6 weeks and 1 year post-RT)
- Correlation of OCT changes with radiation sensitivity(OCT: weeks 1-6 of radiation therapy; FISH: pre-RT)
研究者
Hans Geinitz
Prim. Univ.-Prof. Dr.
Krankenhaus Barmherzige Schwestern Linz