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.
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
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.
Parallel
rice bran
Dietary supplementParticipants in the intervention group will receive a standardized dose of rice bran supplement administered orally each day throughout the course of their radiation therapy. The rice bran used is a natural dietary supplement rich in antioxidants and anti-inflammatory compounds, aimed at reducing the severity and duration of radiation-induced oral mucositis in patients with head and neck cancer.
Incidence of grade ≥ 3 mucositis .
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.
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Christina Milad Lobos
Lead sponsor
German University in Cairo
Sponsor institution
