Capturing the Impact of Craniofacial Damage after Radioiodine Therapy

 描述(申请人提供)：甲状腺癌是美国增长最快的癌症，女性和男性的年增长率分别为4.5%和5.3%。放射性碘可以有效地治疗高危甲状腺癌，从而提高存活率和降低复发率。甲状腺癌的成功治疗导致了越来越多的甲状腺癌幸存者，其中许多是年轻人。然而，放射性碘除了破坏甲状腺癌外，还会损害唾液组织，引起不适和肿胀，反复出现唾液感染，味觉减退， 咀嚼干燥食物困难，唾液腺结石，龋齿增加。这些副作用会对生活质量产生负面影响。尽管认识到了唾液症状，但对危险因素及其与唾液功能的相关性了解较少，代表着知识差距。最近，RAI治疗的额外头面部后果已经被认识到。泪液症状包括干眼症、流泪和结膜炎。鼻部症状包括鼻刺激、鼻干和鼻血。泪腺和鼻腔损伤的真实发生率和后果尚不清楚。在我们开发减少RAI相关发病率的技术之前，测量颅面部副作用的范围和影响是必不可少的。我们将开发和评估患者报告的关于接受放射性碘治疗的分化型甲状腺癌患者的唾液、泪液和鼻部症状的问卷。我们将使用混合方法通过两个相互关联的研究阶段来开发问卷(称为Salans)。在第一阶段，我们将对48名接受放射性碘治疗的甲状腺癌患者进行重点小组研究，以确定头面部症状，并了解这些症状对患者生活质量的影响。在对条目进行定性分析和专家评审后，我们将对16名患者进行新设计的Salans问卷的认知测试。修订后，我们将对80例甲状腺癌患者(50例接受放射性碘治疗，30例未接受放射性碘治疗)进行Salans问卷的初步测试，以建立维度和结构效度。在第二阶段，我们将对50名新诊断为分化型甲状腺癌的患者进行前瞻性队列研究，这些患者将接受放射性碘治疗。我们将在放射性碘治疗前和之后7天以及3、6、9和12个月进行评估。我们将通过唾液流量、唾液核素扫描和血清淀粉酶的测量，将Salans评分与唾液功能的客观测量相关联。这项研究的长期目标是提供一个有效和可靠的问卷，作为未来研究的基础，以预防或改善接受放射性碘治疗的患者的颅面损伤。

 DESCRIPTION (provided by applicant): Thyroid cancer is the most rapidly increasing cancer in the United States, with an annual percentage increase of 4.5% in women and 5.3% in men. High-risk thyroid cancer can be effectively treated by radioactive iodine, which leads to improved survival and decreased recurrence rates. The successful treatment of thyroid cancer has lead to an ever-increasing number of thyroid cancer survivors, many of whom are young. However, in addition to destroying thyroid cancer, radioactive iodine also damages salivary tissue, causing discomfort and swelling, recurrent salivary infections, decreased ability to taste, difficulty chewing dry foods, salivary gland stones, and increased dental caries. These side effects negatively impact quality of life. Despite recognition of salivary symptoms, risk factors and correlation with salivary function are less understood and represent knowledge gaps. Recently, additional craniofacial consequences of RAI treatment have been recognized. Lacrimal symptoms include dry eyes, over-flowing tears, and conjunctivitis. Nasal symptoms include nasal irritation, dry nose, and nose bleeds. The true incidence and consequences of lacrimal and nasal damage are unknown. Measurement of the range and impact of craniofacial side effects is essential before we can develop techniques to minimize RAI-related morbidity. We will develop and evaluate a patient-reported questionnaire of salivary, lacrimal and nasal symptoms in patients with differentiated thyroid cancer who are treated with radioactive iodine. We will use a mixed methods approach to develop the questionnaire (called SALANS) through two linked phases of research. In Phase I, we will conduct focus groups with 48 patients with thyroid cancer treated with radioactive iodine to identify the craniofacial symptoms and understand how these symptoms impact patients' quality of life. Following qualitative analyses and expert review of items, we will conduct cognitive testing of the newly designed SALANS questionnaire in 16 patients. After revision, we will conduct a pilot test of the SALANS questionnaire with a group of 80 patients with thyroid cancer (n=50 treated with radioactive iodine; n=30 not treated with radioactive iodine) to establish dimensionality and construct and discriminant validity. In Phase II, we will conduct a prospective cohort study with 50 patients newly diagnosed with differentiated thyroid cancer who will receive radioactive iodine treatment. We will conduct assessments prior to and then 7-days and 3, 6, 9 and 12 months post radioactive iodine therapy. We will correlate SALANS scores with objective measures of salivary function using salivary flow, performing salivary scintigraphy, and measurement of serum salivary amylase. The long-term goal of this research is to provide a valid and reliable questionnaire that can serve as the underpinning for future studies to prevent or ameliorate craniofacial damage in patients receiving radioactive iodine therapy.