Effects of Rice Bran on Radiation-Induced Oral Mucositis in Patients With Head/Neck Cancer and Its Impact on the Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of grade ≥ 3 mucositis .
研究概览
简要总结
This study aims to find out if taking rice bran supplements can help reduce the painful mouth sores (oral mucositis) that often occur in patients with head and neck cancer who receive radiation therapy. The trial will include adult patients undergoing radiation treatment. Participants will be given rice bran supplements during their therapy to see if it can lessen these side effects and improve their overall quality of life.
详细描述
Radiation-induced oral mucositis is a common and debilitating side effect experienced by patients undergoing radiation therapy for head and neck cancer. This condition causes painful inflammation and ulceration of the mucous membranes in the mouth, significantly impacting patients' ability to eat, speak, and maintain oral hygiene, thereby reducing their quality of life.
This study investigates the therapeutic potential of rice bran, a natural byproduct of rice milling rich in antioxidants and anti-inflammatory compounds, as a dietary supplement to mitigate the severity of oral mucositis. Participants will be adult patients diagnosed with head and neck cancer who are scheduled to receive radiation therapy.
The intervention involves administering rice bran supplements concurrently with radiation treatment. The study aims to evaluate the effects of rice bran on the incidence, duration, and severity of oral mucositis, as well as its overall impact on patients' quality of life during and after treatment.
By assessing clinical outcomes and patient-reported measures, this trial seeks to provide evidence on whether rice bran can serve as an effective, low-cost, and accessible supportive care option for managing radiation-induced oral mucositis.
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
- None
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
- •Male or female patients of age 18 years old tor more
- •Patients with squamous cell carcinomas without metastases of other non-head and non-neck tumors.
- •Patients undergoing radiotherapy with an ECOG performance status of 0, 1, or 2
- •Patients who will receive IMRT delivered as radical or adjuvant therapy with or without concurrent chemotherapy
- •Ready to provide written informed consent
排除标准
- •Receiving any other approved or investigational anti-cancer agent than those specified in this study.
- •Pregnant or breastfeeding female patients
- •Patients who have oral lesions unrelated to treatment or cancer,
- •Patients who are on drugs that could cause oral lesions or are using anticoagulants.
结局指标
主要结局
Incidence of grade ≥ 3 mucositis .
时间窗: From the start of radiation therapy until 2 weeks after completion of treatment (approximately 8 weeks)
The proportion of patients who develop severe oral mucositis of grade 3 or higher, based on standardized clinical grading scales, during or after radiation therapy. Grade 3 mucositis is characterized by severe pain, ulceration, and an inability to eat solid foods without significant discomfort.
次要结局
未报告次要终点
研究者
Christina Milad Lobos
Sponsor-Investigator, Assistant Lecturer
German University in Cairo