SIALENDOSCOPIC MANAGEMENT VERSUS PHOTOBIOMODULATION IN PREVENTION OF RADIATION INDUCED XEROSTOMIA IN HEAD AND NECK CANCER PATIENTS (RANDOMIZED CLINICAL TRIAL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Xerostomia grade
研究概览
简要总结
Radiation induced xerostomia (RIX) represents a common debilitating side effect for (RT), adversely affecting oral health and hindering head and neck cancer (HNC) patients' quality of life (QOL). To date, managing (RIX) is mainly symptomatic, while the only FDA-approved preventive therapeutic agent is Amifostine, with associated systemic toxicities. Sialendoscopic management is a minimally invasive technique that can help in restoring ductal patency, decreasing inflammation and improving salivary flow. Laser Photobiomodulation (PBM) is a noninvasive approach that enhances salivary gland function by stimulating cellular activity, increasing blood flow and attenuating oxidative stress.
Aim: The present study aims to evaluate and compare the efficacy of sialendoscopic management and photobiomodulation in managing (RIX) in (HNC) patients.
Materials and Methods: A randomized clinical trial will be carried out on 42 (HNC) patients. Directly prior to the first (RT) session, Group I (n= 14 patients) will receive sialendoscopic management. Group II (n=14 patients) will receive (PBM) sessions. Group III (n= 14 patients) will receive basic oral care (BOC). Xerostomia will be evaluated at baseline, at 3 weeks and after 8 weeks from the end of (RT), clinically using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and objectively using unstimulated salivary flow. Quality of life will be assessed using Multidisciplinary Salivary Gland Society (MSGS) questionnaire. Salivary amylase will be assessed at baseline and after 8 weeks from the end of (RT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are going to receive (IMRT) as a treatment of (HNC) either as postoperative (adjuvant) therapy or definitive therapy.
- •Patients who are planned to receive (RT) with parotid mean dose bilaterally not exceeding 25 Gy.
- •Males and females with an age not less than 18 years30
排除标准
- •Patients suffering from uncontrolled systemic diseases (such as diabetes, hypertension, cardiovascular, liver or renal dysfunction).
- •Patients with history of using drugs such as (pilocarpine ), oral humidifiers or herbs that prevent or treat xerostomia 2 months prior to study inclusion.
- •Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
- •Patients diagnosed with Sjögren's disease or other underlying systemic illness that is known to cause xerostomia.
研究组 & 干预措施
Group I: Sialendoscopy
Patients in this group will receive sialendoscopic management using an all-in-one 1.3-mm Marchal sialendoscope.
干预措施: Sialendoscopy (Procedure)
Group II: Photobiomodulation
Patients in this group will receive laser photobiomodulation sessions (twice/week) for 6 weeks (total of 12 sessions)
干预措施: Photobiomodulation (Procedure)
Group III: Control
patients in this group will receive Basic oral care only
结局指标
主要结局
Xerostomia grade
时间窗: from baseline to two months following the end of radiation
Xerostomia grade will be assessed based on clinical implications and activity impact from Common Terminology Criteria for Adverse Events (CTCAE) v5.0. at baseline, 3 weeks (during RT) and 8 weeks (after the end of RT)
次要结局
- Quality of life of patients(From baseline to two months after the end of Radiation)
研究者
Basma Morsy
Doctor
Alexandria University