Clinical and Instrumental Evaluation of Late Dysphagia in Naso and Oropharynx Cancer After Swallowing-organs (SWOARs)-Sparing Chemo-IMRT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- To assess the changes of deglutition-related quality of life by means of MDADI questionnaire from before to after radiochemotherapy
研究概览
简要总结
To prospectively assess post-radiation late dysphagia by using MDADI questionnaire (deglutition-related quality of life) and objective instrumental assessment by means of Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Videofluoroscopy (VFS) in patients affected by nasopharynx and oropharynx cancers candidates to radiochemotherapy. Radiotherapy is delivered by using Intensity and Modulated Technique (IMRT) with a planning dose optimization to the swallowing related structures (SWOARs-sparing IMRT).
The primary aim is to assess the variations of MDADI, FEES and VFS from baseline to 6 and 12 months after treatment.
The secondary aim is to correlate clinical and instrumental results as well as radiation dose received by the different swallowing related structures (SWOARs) to the variations of clinical (MDADI) and instrumental (FEES and VFS) scores.
详细描述
The aim of the study is to prospectively investigate the impact of radiochemotherapy on both the deglution-related quality of life (QoL) by means of MDADI questionnaire and the swallowing function by means of Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and Videofluoroscopy (VFS).
Radiotherapy All patients requiring bilateral neck irradiation will be considered.
The clinical target volumes (CTVs) is directly delineated by the radiation oncologist according to the guidelines of the Italian Association of Radiation Oncology-Head and Neck Working Group 27 and the corresponding planning target volumes (PTVs) is automatically created by uniform expansions of 0.3 cm.
Patients positioning is assessed by weekly cone beam CT (CBCT) and online correction to reduce systematic set-up errors.
The prescribed doses is 66 Gy at 2.2 Gy per fraction to the high risk gross volume PTV and 60-54 Gy at 2.0-1.8 Gy per fraction to the intermediate (optional) and low risk subclinical PTVs, respectively, delivered concomitantly in 30 daily fractions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To assess the changes of deglutition-related quality of life by means of MDADI questionnaire from before to after radiochemotherapy
时间窗: Baseline, 6 and 12 months treatment
All patients will be evaluated by using MDADI questionnaire at baseline and at 6 and 12 months after radiochemotherapy. The variations of MDADI questionnaire scores from before to after treatment will be analysed.
To assess the changes of deglutition function by means of Fiberoptic Endoscopic Evaluation of Swallowing (FEES) from before to after radiochemotherapy
时间窗: Before, 6 and 12 months after treatment
All patients will be evaluated by using FEES at baseline and at 6 and 12 months after radiochemotherapy. The variations of FEES scores from before to after treatment will be analysed
To assess the changes of deglutition function by means of Videofluoroscopy (VFS) from before to after radiochemotherapy
时间窗: Before, 6 and 12 months after treatment
All patients will be evaluated by using VFS at baseline and at 6 and 12 months after radiochemotherapy. The variations of VFS scores from before to after treatment will be analysed
次要结局
- To correlate MDADI score (deglutition-related quality of life) changes with FEES and VFS score (deglutition function) changes from before to after treatment(Before, 6 and 12 months after treatment)
- To correlate radiation dose features received by the different swallowing related structures (SWOARs) to the changes of MDADI, FEES and VFS scores from before to after treatment by using a Machine Learning Methodology(At baseline and at 6 and 12 months)
研究者
Stefano Ursino, MD
Researcher
Azienda Ospedaliero, Universitaria Pisana