Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Oral Mucositis
研究概览
简要总结
Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.
Gel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations.
The aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.
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)
盲法说明
The principal investigator will be encharged of generating the allocation sequence, of enrolling the participants and of assigning the interventions to the participants.
The coworkers who will evaluate the onset of OM and its severity will be blinded about the selected product.
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 diagnosis of the following HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy for curative purpose
- •Patients with diagnosis of HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy as an adjuvant to surgical resection
- •Patients able self-apply the product.
排除标准
- •Patients with documented contraindication to any of the components of "Gel X" (there included eccipients): water, saccharin sodium, PVP, Taurine, Zinc Gluconate, PEG-40, Hydrogenated castor oil, Pullulan, Flavors
- •Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment
- •Patients participating to other clinical studies
结局指标
主要结局
Oral Mucositis
时间窗: One week after the end of Radiotherapy
Yes/No
次要结局
- Time of Oral Mucositis Onset(From Day 0 to 2 months)
- Severity of Oral Mucositis(One week after the end of Radiotherapy)
研究者
Carlo Lajolo
Prof.
Catholic University of the Sacred Heart