Evaluation of the Prognostic Value of Aerodigestive Tract Ultrasound in the Occurrence of Radiotherapy-related Swallowing Disorders in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The primary endpoint is the predictive ability of morphology and/or movement of the tongue, hyoid bone and suprahyoid muscles measured by ultrasound on the occurrence of TDs during radiotherapy.
研究概览
简要总结
Radiotherapy for head and neck cancers (H&NC) heightens the risk of swallowing disorders (SD), impacting nutrition, quality of life, and overall health, leading to increased hospitalization and mortality. Dietary plans hinge on patients' nutritional status, swallowing ability, and prognosis. Early interventions are crucial, emphasizing the need for precise assessments guiding prognosis, specifying structures for intervention, and facilitating targeted rehabilitation.
Clinical examinations lack precision, while existing complementary methods like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing are invasive, irradiating, resource-intensive, and challenging to access, with uncertain prognostic values.
Ultrasound imaging emerges as a non-invasive alternative, offering morphological and dynamic evaluation of swallowing-related structures. It enables qualitative and quantitative analyses, improving precision in targeting structures for rehabilitation. Researchers propose an ultrasound predictive model to anticipate SD risk during H&NC radiotherapy, assessing its reliability and accuracy.
Over eighteen months, 124 outpatients beginning H&NC radiotherapy at Forcilles's Hospital will undergo weekly clinical and water-swallow tests by a speech language therapist, with videofluoroscopy when SD is suspected. Ultrasound evaluations pre-treatment and at seven and fourteen days will be conducted by blinded ultrasonographers. Cox models will test ultrasound measurement thresholds for SD prediction, estimating sensitivity, specificity, and prediction values. A global ultrasound predictive model will be developed via logistic multivariable regression.
The study aims to establish an association between ultrasound markers and SD, improving early detection for tailored management. This non-invasive alternative to videofluoroscopy offers potential for enhancing patient outcomes in H&NC radiotherapy.
详细描述
Radiotherapy for head and neck cancers increases the risk of Swallowing Disorders (SD), which can have serious consequences for nutrition, quality of life, and overall health.
Early intervention strategies could greatly benefit, highlighting the importance of assessments offering insights into patients' prognosis, identifying which specific structures require intervention and enabling a targeted rehabilitation approach.
However, the clinical examination lacks precision. Complementary examinations, such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES), are irradiating or invasive, consume numerous resources and are difficult to access. What's more, their prognostic values are not known.
In this context, ultrasound imaging has garnered increased interest for assessing swallowing disorders. Recognised for its non-invasive nature and its ability to overcome conventional constraints, ultrasound holds promise in integrating morphological and dynamically swallowing-related structures evaluation. This approach, enabling both qualitative and quantitative analysis of multiple structures, would enhance the precision in targeting structures for rehabilitation.
The researchers intend to create an ultrasound predictive model to anticipate the risk of developing swallowing disorders during head and neck cancer radiotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to Hôpital Forcilles for head and neck cancer radiotherapy;
- •Ultrasound operator available ;
- •Patient at least 18 years old at the time of inclusion;
- •Membership of a social security scheme or beneficiary of such a scheme ;
- •Oral, free, informed and express patient consent.
排除标准
- •Patients with neurological disorders;
- •Patients with DR before the start of radiotherapy;
- •Patient's refusal to participate in the study ;
- •Person subject to a safeguard of justice measure ;
- •Patient under guardianship;
- •Patient with limited care.
结局指标
主要结局
The primary endpoint is the predictive ability of morphology and/or movement of the tongue, hyoid bone and suprahyoid muscles measured by ultrasound on the occurrence of TDs during radiotherapy.
时间窗: On the day of the initial radiotherapy session, preceding the treatment
Swallowing disorders will be diagnosed by videofluoroscopy wich will be performed when swallowing disorder is suspected or at the end of radiotherapy treatment.
次要结局
- Inter and intra-rater evaluation(On the day of the initial radiotherapy session, preceding the treatment)
- To describe the changes in ultrasound measurements after 5 and 10 sessions of radiotherapy(On the day of the initial radiotherapy session and 7 and 14 days afterward)