背景:吞咽困难,对预期寿命和生活质量的负面影响,是头颈部鳞状细胞癌(HNSCC)的主要副作用。在一个典型的头颈部癌症中心,超过一半的患者受到影响。改善治疗,理想的是分别预防康复,因此,似乎比可取的。
方法:该研究计划作为单中心,prospective,结果盲化,随机介入研究比较了一项先进的心血管外科康复治疗与对照(标准护理)。70例患者(对照组30例,30个干预组,在17个月的时间内,将包括对侵入性HNSCC的初步诊断和治愈性治疗意向的10个脱落率15%)。除了以前的标准,两组均通过各种问卷对吞咽功能和生活质量进行详细的主观评估,并通过生物电阻抗测量和超声内镜吞咽检查进行客观分析.在干预组中,提供与风险相关的营养咨询(面对面)和Phoniatric-logoparic康复治疗:详细的咨询,视频演示和练习,以加强和改善口腔的活动范围,咽部,和喉部肌肉(由运动日记指导)。在6周进行对照,3和6个月,治疗结束后9个月或12个月,定期进行肿瘤随访。主要研究终点是控制访视6周时的吞咽功能和情绪困扰。
结论:在其他患者组中,康复措施已经证明是成功的。例如,移植患者在头颈部肿瘤学领域,近年来,人们对这些概念的兴趣显著增加。然而,通常,只有子组,例如,单纯放化疗后出现吞咽问题的患者,是焦点。我们的研究旨在探讨康复治疗对吞咽功能的一般益处,这对保护愿望和生活质量非常重要。
背景:德国临床试验注册DRKS00029676。国际临床试验注册平台DRKS00029676。2022年7月19日注册。
BACKGROUND: Dysphagia, with its negative impact on life expectancy and quality of life, is a major side effect of head and neck squamous cell carcinoma (HNSCC). In a typical Head and Neck Cancer Center, more than half of patients are affected. Improving treatment, and ideally prevention respectively prehabilitation, therefore seems more than desirable.
METHODS: The
study is planned as a monocentric, prospective, outcome-blinded, randomized interventional
study comparing an advanced phoniatric-logopedic prehabilitation with a control (standard of care). Seventy patients (30 control group, 30 intervention group, 10 drop-out rate of 15%) with an initial diagnosis of invasive HNSCC and curative treatment intention will be included over a period of 17 months. In addition to the previous standard, both groups will undergo both detailed subjective assessment of swallowing function and quality of life by means of various questionnaires and objective analyses by bioelectrical impedance measurements and phoniatric endoscopic swallowing examinations. In the intervention group, risk-related nutritional counseling (face-to-face) and phoniatric-logopedic prehabilitation are provided: detailed counseling with video demonstration and exercises to strengthen and improve the range of motion of the oral, pharyngeal, and laryngeal muscles (guided by exercise diary). Controls are performed at 6 weeks, 3 and 6 months, and 9 or 12 months after the end of therapy during the regular tumor follow-up. Primary
study endpoints are swallowing function and emotional distress at 6 weeks of control visit.
CONCLUSIONS: Prehabilitation measures have already proven successful in other patient groups, e.g., transplant patients. In the field of head and neck oncology, interest in such concepts has increased significantly in recent years. However, usually, only subgroups, e.g., patients with swallowing problems after radiochemotherapy alone, are in focus. Our
study aims to investigate the general benefit of prehabilitation with regard to swallowing function, which is so important for protection of aspiration and quality of life.
BACKGROUND: German Clinical Trials Register DRKS00029676 . International Clinical Trials Registry Platform DRKS00029676 . Registered on 19 July 2022.