A Randomized Controlled Trial of the Effectiveness of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Grade of sialadenitis
研究概览
简要总结
The purpose of this study is to determine whether the use of honey mouthwashes in the prevention of salivary side effects of 131I (radioiodine) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •They had a histological diagnosis of papillary, follicular, medullary or anaplastic thyroid cancer
- •They had undergone total thyroidectomy
- •They were able to provide consent
排除标准
- •patients who had distant metastases,
- •a history of salivary-gland disorders,
- •collagen tissue disease
- •diabetes mellitus,
- •previous radioiodine therapy or external radiation to the head or neck
- •allergy to the honey
研究组 & 干预措施
Candy plus thymus honey mouthwash 12
This arm will consist 30 patients and will be the one of the intervention groups where each patient will be instructed to suck 1 or 2 lemon candies every 2-3 h in the daytime plus 4 thymus honey mouthwashes in between (at least one hour after the candy sucking) starting 12 hours after the ingestion of 131I therapy and for a duration of no more than 4 days.
干预措施: thymus honey mouthwash (Dietary Supplement)
Candy plus thymus honey mouthwash 24
This arm will consist 30 patients and will be the one of the intervention groups where each patient will be instructed to suck 1 or 2 lemon candies every 2-3 h in the daytime plus 4 thymus honey mouthwashes in between (at least one hour after the candy sucking) starting 24 hours after the ingestion of 131I therapy and for a duration of no more than 4 days.
干预措施: thymus honey mouthwash (Dietary Supplement)
Candy plus thymus honey mouthwash 1
This arm will consist 30 patients and will be the one of the intervention groups where each patient will be instructed to suck 1 or 2 lemon candies every 2-3 h in the daytime plus 4 thymus honey mouthwashes in between (at least one hour after the candy sucking) starting immediate after the ingestion of 131I therapy (about 1 hour) and for a duration of no more than 4 days
干预措施: thymus honey mouthwash (Dietary Supplement)
Standard care
This arm represents the current standard care in patients with thyroid cancer undergoing radioiodine.
结局指标
主要结局
Grade of sialadenitis
时间窗: Change from Baseline grade of sialadenitis at 6 and 24 months
次要结局
- Grade of Xerostomia(Change from Baseline grade of xerostomia at 6 and 24 months)
- Level of Health related quality of life(Change from Baseline level of health related quality of life at 6 and 24 months)
研究者
Dr. Andreas Charalambous
Assistant Professor of Oncology and Palliative Care
Cyprus University of Technology