Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients A Randomized Controlled Clinical Trial With a Biochemical Assessment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- subjective dry mouth score
研究概览
简要总结
Xerostomia is the most frequent complication among patients who receive radiotherapy (RT) . The prevalence of xerostomia has been reported to be from 73.5% to 93% (Kakoei S.,2012). Damage to normal tissues can result by radiotherapy as it is not selective to cancer cells, and so affecting the quality of life of patients. Honey is one of the methods studied by CIM for management of HNC treatment side effects due to its properties. (Brennan et al., 2002; Clarkson et al., 2007; Furness et al., 2011;Hackett et al., 2015).
Thyme honey is a new alternative for management of xerostomia, which is a propolis gel product. Thyme honey is a variety of monofloral honey made from the nectar and pollen of thyme flowers. It has a strong antioxidant, antibacterial, antifungal and immuno modulating health effects. Due to the high sugar concentration in honey, it is believed that its presence in the oral cavity has a sialogogue effect, stimulating the salivary glands to produce saliva.
详细描述
90 post radiation cancer patients were randomly assigned into two equal groups.The intervention group will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. Patients in the control arm followed the same protocol with normal saline rinses. The treatment assessment of subjective dry mouth score, objective dry mouth score, salivary Ph and salivary flow rate will be carried out at baseline, 2 weeks and one month after starting of the treatment protocol (Charalambous et al., 2017).
Nitric oxide levels will be measured at baseline and after one month of treatment (Abadi et al., 2020).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to non-palliative head and neck radiotherapy
- •Total dose of radiation received (50-70 Gy)
- •Patients with complaint of xerostomia
- •Age 25-65 years old
- •Objective dry mouth score from ( 2-5)
- •Subjective dry mouth score from (1-4)
- •Undergoing radiotherapy for at least three weeks
- •Can independently complete the questionnaire
排除标准
- •Have confirmed systemic diseases or medications associated with xerostomia
- •Have a known allergy to honey
- •Patients who had salivary glands removal surgery
- •Patients with salivary gland diseases or malignancy
- •Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
研究组 & 干预措施
thyme honey
oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017)
干预措施: thyme honey mouth rinse (Drug)
Saline
oral rinses with saline 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy.
干预措施: saline mouth rinse (Drug)
结局指标
主要结局
subjective dry mouth score
时间窗: change from baseline at 4 weeks
Q1. Do you feel dryness in your mouth ? Q2. Do you drink liquids to help you swallow dry food? Q3. Do you feel mouth dryness when eating a meal? Q4. Does the saliva seem to be too little in your mouth? Subjects who answered confirmatively to at least one of those questions related to dry mouth will be considered as positive for oral dryness subjective complaints.
次要结局
- salivary PH(change from baseline at 4 weeks)
- Salivary flow rate(change from baseline at 4 weeks)
- objective dry mouth score(change from baseline at 4 weeks)
- nitric oxide levels(change from baseline at 4 weeks)
研究者
Dina Magdi
teaching assistant of oral medicine and periodontology
Ain Shams University