The Effectiveness of a Thyme and Honey Spray for the Management of Oral Mucositis and Xerostomia in Head and Neck Cancer Patients Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change from baseline in Mucositis Grade (RTOG) at weekly assessments
研究概览
简要总结
Aim: To evaluate the effectiveness of thymus honey on radiation induced-oral mucositis and xerostomia.
Background: Oral mucositis and xerostomia are two of the most severe side effects that head and neck cancer patients confront during and after the completion of radiotherapy. Although several medications are used for their treatment, these fail to provide a fully effective and comprehensive management. Honey and thyme have been studied for the management of various treatment-related side effects.
Design: Α double blinded randomised controlled trial will be used for this study.
Methods: 200 head and neck cancer patients who receive radiotherapy will be included in this study. Patients will be randomised and divided into two equal groups of 100 participants; the intervention group (oral spray with thyme and honey + standard care) and the control group ( placebo spray + standard care). Assessments with xerostomia and oral mucositis scales additionally to 4 self-administered questionnaires will occur in both groups at baseline and then weekly and 6 months following completion of treatment. The duration of the study will be 3 years from the day of approval of this research protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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 with a confirmed histologic diagnosis of head and neck cancer
- •Patients referred to non-palliative radiotherapy to the oral cavity will be included in the study
- •Synchronous or induction chemotherapy, or both, will be permitted.
- •Patients aged over 18,
- •Patients able to provide informed consent,
- •Patients having radiotherapy for at least three weeks (lower limit has been set at 50 Gy),
- •Patients able to complete records accurately
排除标准
- •Patients with a confirmed and medically treated diabetes mellitus,
- •Patients with allergy to honey, thyme or any other ingredient,
- •Patients who will refuse to take part in this study and
- •Patients with previous radiotherapy or presence of systemic disease.
结局指标
主要结局
Change from baseline in Mucositis Grade (RTOG) at weekly assessments
时间窗: Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
The scale includes 5 grades (from 0 to IV). Higher grade denotes more severe mucositis
Change from baseline in Xerostomia Grade (CTCAE) at weekly assessments
时间窗: Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
he scale includes 5 grades (from 0 to IV). Higher grade denotes more severe xerostomia
次要结局
- Change from baseline in Xerostomia Questionnaire (Dirix et al)(Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy)
- Change from baseline in Oral Mucositis Questionnaire (OMWQ)(Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy)
- Change from baseline in health-related QoL (EORTC QLQ-C30) questionnaire(Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy)
- Change from baseline in health-related QoL (EORTC QLQ-H&N43) questionnaire(Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy)
研究者
Dr. Andreas Charalambous
Associate Professor
Cyprus University of Technology