Effect of Prophylactic Use of Oral Vitamin D and Zinc in Management of the Severity of Radiation Induced Oral Mucositis of Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- oral mucositis scale
研究概览
简要总结
The main aim of this study was to evaluate clinically the effect of a combination between oral vitamin D and oral zinc in comparison to conventional therapy in prevention of radiotherapy-induced oral mucositis in Assiut University Hospitals.
详细描述
Most head and neck cancers are derived from the mucosal epithelium in the oral cavity, pharynx and larynx and are known collectively as head and neck squamous cell carcinoma (HNSCC). Oral cavity and larynx cancers are generally associated with tobacco consumption, alcohol abuse or both, whereas pharynx cancers are increasingly attributed to infection with human papillomavirus (HPV), primarily HPV-16. Thus, HNSCC can be separated into HPV-negative and HPV-positive HNSCC.
As a major histological type of HNC, head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer worldwide. Totally, 53,000 new cases and 10,860 HNC-related deaths were observed in the U.S. in 2019. According to the estimation of the World Health Organization, 439,000 mouth and oropharynx cancer will be observed in 2030.
The main treatment options are surgery, radiation therapy, chemotherapy, targeted therapy, and immunotherapy.
Treatment options and recommendations depend on several factors, including the type and stage of head and neck cancer, possible side effects, and the patient's preferences and overall health.
Radiation therapy (RT) plays a key role in curative-intent treatments for head and neck cancers. Its use is indicated as a sole therapy in early stage tumors or in combination with surgery or concurrent chemotherapy in advanced stages. Recent technologic advances have resulted in both improved oncologic results and expansion of the indications for RT in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Selection of patients
- •All adults (18 years or older ), who were confirmed based on pathology ( Head and Neck Squamous Cell Carcinomas ), will administere chemo-radiotherapy either as preoperative (neoadjuvant), postoperative (adjuvant) therapy or definitive therapy, no randomization .
- •The treatment group will receive combined oral Vit D and Zinc and the control group will take placebo capsules or receive no treatment.
- •No documentation of any other causes of oral mucositis in their medical records as : immunocomprmized patients d.t HIV
排除标准
- •Non Head and Neck cancer
- •patients with any other causes of oral mucositis
- •Double malignancy
- •Un eligible patients for radiotherapy ( comatosed, bedridden and sever chest disease )
研究组 & 干预措施
vit D and zinc group
will receive combination of oral vit D and zinc 30 patients
干预措施: Vitamin D (Drug)
结局指标
主要结局
oral mucositis scale
时间窗: baseline
The Oral Mucositis Assessment Scale (OMAS) is an objective scale that measures erythema and ulceration at nine sites within the oral cavity grade0:(none) grade1(mild): oral soreness and erythema grade 2(moderate):oral erythema ,ulcers, solid diet tolerance grade 3(sever) :liquids diet only grade 4(life threatening) oral alimentation impossible
次要结局
未报告次要终点
研究者
Shorooq Mostafa Kamel Ahmed
resident doctor at clinical oncology and nuclear medicine
Assiut University