Retrospective Evaluation of Severe Oral Mucositis Incidence, Time to Onset and Functional Impact in Quality of Life in Head and Neck Cancer Radiated and Chemo-radiated Patients. Part of the Stop Oral Mucositis Project (STOPOMP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of severe oral mucositis (grade 3-4) in Head & Neck cancer patients who had been treated with radiotherapy (with or without concomitant chemotherapy) and had received the topical mucosa support during 6 weeks.
研究概览
简要总结
Head and Neck cancer patients receiving radiation therapy (with or without chemotherapy) suffer several oral complications, such as oral mucositis, which impairs quality of life of patients during radiotherapy and in the post-treatment follow-up period. The use of topical agents to protect oral mucosa against radiation-induced toxicity is part of the routine clinical practice. Among these products, the use of mouthwashes and/or gels are extensively used in the Centro Oncológico Clara Campal - Hospital HM Sanchinarro. Once such product is a proprietary formulation based on natural ingredients such as olive oil, betaine, and xylitol (Mucosa Innovations S.L.).
详细描述
Radiotherapy, with or without chemotherapy, is the standard treatment for patients diagnosed with head and neck cancer, a disease that accounts for approximately 5% of all cancers diagnosed worldwide and whose incidence is estimated to increase by approximately 64% by 2050. Head and neck cancer is the sixth most common cancer worldwide, with a 5-year survival rate of 50-60%.
Treatment with radiotherapy (RT) or chemoradiotherapy (CRT) in patients with head and neck cancer is frequently associated with the development of acute complications affecting the oropharyngeal cavity, such as oral mucositis, a common toxicity that may lead to multiple functional consequences during oncological treatment. Medium- to long-term complications, also referred to as chronic complications, significantly affect quality of life and include dysphagia, odynophagia, xerostomia, loss of taste, mucosal atrophy, and fibrosis, among others.
Oral mucositis, the most common oral complication during treatment, affects 90-100% of patients with head and neck cancer treated with radiation therapy. The incidence of severe oral mucositis (WHO grade 3-4) in patients with head and neck cancer receiving chemoradiotherapy is approximately 65-70%, whereas in those receiving radiotherapy alone, the incidence is 57%.
In some patients, mucositis may cause significant oral pain that impacts food and fluid intake, leading to serious difficulties and limitations in nutrition and a substantial deterioration in quality of life. Furthermore, in severe cases, oral mucositis may result in additional complications such as infections, treatment interruptions and delays, and even treatment discontinuation.
The literature indicates that severe forms of oral mucositis are responsible for 20-30% of early interruptions in oncological treatment, potentially compromising treatment success and patient survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adults (≥18 years) diagnosed with head and neck cancer
- •Treated with radiotherapy or chemoradiotherapy, with or without surgery and/or immunotherapy, according to tumor type and stage, between 2019 and 2023
- •With available medical records documenting clinical assessments of oral mucositis during at least the radiotherapy/CRT treatment period, and that had used the oral mucosa topical measures
排除标准
- •Patients with missing or insufficient clinical records required for the study
- •Patients with concomitant malignancies undergoing active treatment at the same time.
结局指标
主要结局
Incidence of severe oral mucositis (grade 3-4) in Head & Neck cancer patients who had been treated with radiotherapy (with or without concomitant chemotherapy) and had received the topical mucosa support during 6 weeks.
时间窗: Six weeks during radiotherapy.
Oral mucositis severity data will be collected retrospectively from medical records in which assessments had been performed by the clinician using the WHO scale (grade 0-4; 0: no remarkable findings, 1: erythema and discomfort, without ulcers, 2: erythema and ulcers, but able to tolerate solid food; 3: ulcers, only able to tolerate liquids; 4: unable to tolerate solids or liquids), at weekly intervals during the 6 weeks of treatment.
次要结局
- Time to onset of severe oral mucositis (grades 3-4) in Head & Neck cancer patients who had been treated with radiotherapy (with or without concomitant chemotherapy) and had received the topical mucosa support during 6 weeks.(Six weeks during radiotherapy.)
- Impact of oral complications experienced by Head & Neck cancer patients during their 6-week radiotherapy (with or without concomitant chemotherapy) and had received the topical mucosa support during 6 weeks.(Six weeks of radiotherapy.)