The Characterisation of Therapeutic Radiation-induced Caries; the Histopathological, Ultrastructural and Microbial Changes Affecting Its Prevention and Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Effects of IMRT on saliva composition and potential associations with oral side effects
研究概览
简要总结
Overcoming limitations of previous studies, the following research project will assess the most significant acute and long-term complications of RT that affect HNC patients: oral mucositis, dry mouth feeling, taste alteration and carious lesion incidence, all of which negatively affect cancer treatment outcomes and the quality of life of cancer survivors. This project was developed with an aim to study any possible correlations / links between the oral sequelae of RT and the negative clinical outcomes listed, in order to help the development of clinical management protocols for HNC patients to mitigate the effect on care and patient comfort and its delivery in healthcare systems.
The project comprises of a longitudinal cohort study of HNC patients correlating biodata of biochemical salivary parameters, clinical outcomes and oral health status over a period up to 12 months post-RT, focusing on baseline pre-IMRT (T0), 6 months post-IMRT (T1) and up to 12 months post-IMRT treatments (T2). The ultimate goal is to identify possible predictive markers in the saliva at T0 to assist with evaluation of oral mucositis severity in individual HNC patients prior to start of treatment so that treatment can be adapted for such high-risk patients individually, to either prevent or minimise the severity of this consequence of RT.
详细描述
- Introduction
Head and neck cancer is the sixth most common cancer in the world representing 4-5% of all malignancies . Head and neck cancer (includes oral, nasal cavity, salivary glands, paranasal sinus, pharynx, and larynx) is one of the top 10 most diagnosed cancers in the UK . According to Cancer Research UK, there were 7591 newly diagnosed with oral cancer in 2013 in the country, representing the 14th most common cancer in the UK.
Radiotherapy (RT) is the first choice treatment for the majority head and neck cancer patients, which is a localized treatment to control the tumour . More than 50% of head and neck cancer patients receive RT delivered in fractions of 2 Grays (Gy) daily during 5 days per week until the end of their therapy dosage (mean cumulative dose 55-77 Gy). RT stimulates cellular changes that destroy the tumor cells, but may affect dramatically the healthy oral tissues altering the homeostasis of this complex environment. RT is the cause of a wide range of adverse oral tissue reactions such as permanent damage of the major and minor salivary glands (hyposalivation, xerostomia), modification of connective and vascular tissues and a reduction the healing capacity especially in mucosal and mineralised tissues (mucositis, caries lesion, osteoradionecrosis). In order to try to diminish the adverse side effects of the RT three-dimensional (3D) computed tomography (CT) planned radiotherapy known as intensity-modulated radiotherapy (IMRT) has been developed .
There are acute (mucositis) and late-onset adverse effects/sequelae that RT induces in healthy oral tissues . Radiation-induced dental caries is the most common late effect, but its origin and nature is not clear. RT related caries have a rapid onset as a result of a combination of factors such as shift in oral microbial community composition favouring acidophilic bacteria, hypo-salivation, poor oral hygiene and dietary alterations . The patients often have little/no pain, even in the most severe cases. Histological features show that the onset and development of caries is similar to non RT-related ones but the sites affected are different. Indeed RT-related caries is more frequent on the cervico-labial surface/ incisal edge of canines and incisors while non RT-related ones are more frequent in the interproximal/ occlusal areas of the posterior teeth (molar and premolars).
Also, caries associated with RT has a rapid circumferential progression which may lead to tooth fracture. It is characterized by a localized lesion to the incisal or occlusal surfaces which diffuse and progress in relation to irregular and generalized erosion of the incisal edge of the tooth. In addition, mechanical changes (increased elastic modulus and stiffness) within the tooth structure increase the wear of the incisal and occlusal areas and could lead to complete fracture of the tooth.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Head and Neck Cancer Patients Male or female Over the age of
- •Received radiation treatment for Head and Neck cancer
排除标准
- •Subjects younger than
- •Patients unable to give consent. Patients with non-controlled systemic disease Distant metastases Patients who have been administered antibiotics in the previous 3 months Patients with Sjogren syndrome. Patients with Rheumatoid arthritis Neurological disorders (Parkinson's disease) Dehydration Sialoadenitis Sialolithiasis
结局指标
主要结局
Effects of IMRT on saliva composition and potential associations with oral side effects
时间窗: october 2019
integrated longitudinal study of HNC patients correlating biodata of biochemical parameters, clinical parameters and oral health status
次要结局
- IMRT effects on oral cavity(2019)
- IMRT effects on biochemical composition of saliva(2019)
- Association between selected salivary proteins and oral mucositis outcomes after IMRT(2019)
