Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

 描述(申请人提供)：积极的多模式治疗口腔和口咽癌改善了局部控制和存活率；然而，结果的改善往往以显著的急性和晚期治疗效果为代价。淋巴水肿和纤维化(LEF)是这一人群中一种常见但未被充分认识的晚期效应。LEF可同时涉及外部结构(例如，面部)和内部结构(例如，舌头)。LEF的严重程度与严重的症状负担、功能障碍和生活质量下降有关。然而，口腔和口咽癌患者LEF的测量是具有挑战性的。目前，还没有心理测量学验证的患者报告的结果测量方法可用于评估这一人群中的LEF。我们最近发表的文章指出，现有的临床医生报告的头颈外LEF的结果测量方法是有问题的。Patterson分级用于评估内膨胀度的研究很少，因为目前还没有开发出衡量内LEF的标准。然而，Patterson量表未能涵盖可能发展为LEF的重要解剖部位(例如，口腔舌头)。此外，常用的成像技术(CT扫描和超声检查)可以提供客观的信号，以可视化口腔和颅面结构中与LEF相关的软组织变化。然而，这些常用的成像方式还没有被系统地评估是否可以用于评估这一人群中的LEF。国家牙科和颅面研究所(NIDCR)2009-2013年战略计划，目标III-1指出：“开展精心设计的、明确的临床研究，以改善口腔、牙科和颅面健康，并支持更有效的护理提供和卫生政策。”NIDCR强调需要“开发新的方法来实现这一目标”。为了与NIDCR战略计划保持一致，在我们的先导研究中，我们开发了患者报告的结果测量和临床医生报告的头颈部LEF的结果测量。这项研究的主要目标是建立一种有效的、临床上有用的头颈部LEF测量组件。具体目的是：1)确定用于评估口腔和口咽癌患者LEF相关症状的患者报告结果指标(LSID-H&N)的可靠性和有效性；2)确定临床医生报告的结果指标(HN-LEF分级标准和改进的Patterson评分)用于评估外部和内部LEF的可靠性和有效性；以及3)确定成像技术(CT扫描和超声灰阶及应变弹性成像)在确定口腔和口咽癌患者治疗、恢复和生存过程中特定部位LEF方面的可靠性和有效性。我们计划通过以下方式招募120名参与者 一项为期四年的纵向研究。数据收集将在治疗前、治疗结束和癌症治疗后每3个月至12个月进行一次。如果我们的目标能够实现，临床医生将能够使用有效的措施来：1)识别LEF相关症状；2)转介合适的患者进行LEF治疗；以及3)监测治疗结果。将为研究人员提供今后在这一领域进行调查所急需的工具。

 DESCRIPTION (provided by applicant): Aggressive multi-modality therapy for oral cavity and oropharyngeal cancer have improved local control and survival; however, improved outcomes are often at the expense of significant acute and late treatment effects. A common but under-identified late effect in this population is lymphedema and fibrosis (LEF). LEF may involve both external (e.g., face) and internal structures (e.g., tongue). LEF severity is associated with substantial symptom burden, functional impairments, and decreased quality of life. However, measurement of LEF in oral cavity and oropharyngeal cancer patients is challenging. Currently, no psychometrically validated patient- reported outcome measure is available to evaluate LEF in this population. Our recent publication indicated that available clinician-reported outcome measures for external head and neck LEF are problematic. The Patterson Scale has been used in few studies to evaluate internal swelling as no current standard measure of internal LEF has been developed. However, the Patterson Scale fails to capture important anatomical sites (e.g., oral tongue) that may develop internal LEF. In addition, commonly used imaging techniques (CT scan and ultrasonography) may provide objective signals to visualize LEF-related soft tissues changes in the oral and craniofacial structures. However, these frequently used imaging modalities have not been systematically evaluated for possible use in assessing LEF in this population. The National Institute of Dental and Craniofacial Research (NIDCR) Strategic Plan 2009-2013, Objective III-1, states: "Conduct well-designed, definitive clinical research studies that improve oral, dental, and craniofacial health and support more effective care delivery and health policies." The NIDCR emphasizes the need to "develop new approaches to meet this objective." In keeping with the NIDCR Strategic Plan, we developed a patient-reported outcome measure and a clinician- reported outcome measure for head and neck LEF in our pilot studies. The primary goal of this study is to establish a valid, clinically useful measurement battery for head and neck LEF. Specific Aims are to: 1) determine the reliability and validity of the patient-reported outcome measure (LSIDS-H&N) for assessing LEF- related symptoms; 2) determine the reliability and validity of the clinician-reported outcome measures (HN- LEF Grading Criteria and Modified Patterson Scale) for assessing external and internal LEF; and 3) determine the reliability and validity of imaging techniques (CT scan and ultrasound with grayscale and strain elastography) in identifying site-specific LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival. We plan to recruit 120 participants via a four-year, longitudinal study. Data collection will take place at pre-treatment, end of treatment and every 3-months up to 12-months post cancer treatment. If our aims are achieved, clinicians will be able to use the validated measures to: 1) identify LEF associated symptoms; 2) refer appropriate patients for LEF treatment; and 3) monitor the results of therapy. Researchers will be provided with much needed tools for future investigations in this area.