Evaluation of submandibular salivary gland function using quantitative pertechnetate scintigraphy and estimation of dose–response relationship of submandibular gland sparing radiotherapy in head-neck cancers.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared at 6 months post-radiation.
研究概览
简要总结
One of the main treatments for cancers of the head and neck is radiotherapy. Dry mouth is a frequent complication of radiation to the head and neck region. Reducing the amount of radiation to the salivary glands is necessary to reduce dry mouth. Normally the largest salivary gland called the parotids is not allowed to receive a high dose of radiation during planning of radiation to reduce the frequency of dry mouth. The submandibular glands located under the jaw produce most of the saliva at rest and during sleep. As it frequently lies close to the tumour, the amount of radiation going to the submandibular gland cannot usually be restricted. However, depending on the tumour position, it is possible to reduce the amount of radiation to the submandibular glands without compromising on tumour dose. Currently, there are very few studies that have found out how different doses of radiation to the submandibular gland alter its functions. The purpose of this study is to evaluate the function of the salivary glands before and after radiation using a method called salivary scintigraphy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients over 18 years of age
- •Patients with ECOG performance status
- •Patients of squamous cell carcinoma of the head and neck planned for radical radiation with or without concurrent chemotherapy treated with volumetric modulated arc radiotherapy.
排除标准
- •Patients with previous history of radiotherapy to head and neck
- •Patients with carcinoma of the head and neck in whom the submandibular glands are enclosed completely in the clinical target volume.
- •Tumour involvement of both the submandibular glands
- •Pre–existing salivary gland disease
- •Previous or concurrent illness that would compromise completion of treatment or follow-up
- •Patient receiving prophylactic amifostine or pilocarpine.
结局指标
主要结局
To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared at 6 months post-radiation.
时间窗: To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared at 6 months post-radiation.
次要结局
- To assess the correlation between Umax and patient reported outcomes measured using xerostomia questionnaire (XQ)(3 months, 6 months and 1 year post radiation)
- To assess the correlation between the Umax and unstimulated and stimulated salivary flow rate measured by sialometry.(3 months, 6 months and 1 year post radiation)
- To assess the correlation between relative change in the excretion rate and the mean submandibular doses.
- To assess the maximum salivary uptake (U max) for the normal submandibular glands pre- radiation(Pre-radiation)
- To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared(3months and 1 year post-radiation)
- To assess the relative change in the excretion rate (ΔF) between patients whose submandibular glands were spared compared to those in whom they were not spared(3months, 6 months and 1 year post radiation)
- To assess the correlation between Umax and the mean submandibular doses
- To assess the correlation between relative change in the excretion rate and patient reported outcomes measured using xerostomia questionnaire (XQ)(3 months, 6 months and 1 year post radiation)
- To assess the correlation between the relative change in the excretion rate and unstimulated and stimulated salivary flow rate measured by sialometry.
- To assess the excretion rate for the normal submandibular glands pre- radiation.(Pre-radiation)