Rice Bran Supplementation for Radiation-Induced Oral Mucositis in Head and Neck Cancer (RICE-MUC)

Effects of Rice Bran on Radiation-Induced Oral Mucositis in Patients With Head/Neck Cancer and Its Impact on the Quality of Life

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.

Study Overview

• Status: Recruiting
• Conditions: Head &Amp; Neck Cancer; Head &Amp; Neck Squamous Cell Carcinoma; Radiation-Induced Oral Mucositis
• Intervention / Treatment: Dietary supplement: rice bran

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Milad Lobos, Master; Phone Number: +20 1005279101; Email: Krstina.Bqtr@pharm.aun.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • German University in Cairo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rice Bran Supplement Group; Participants in this group will receive rice bran supplements daily during their radiation therapy. The supplement is intended to reduce the severity of oral mucositis and improve quality of life.	Dietary supplement: rice bran; Participants 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.; Other Names: Oryza
No Intervention: Control Group (Standard Care); Participants in this group will receive standard care during radiation therapy without rice bran supplementation. Their oral mucositis symptoms and quality of life will be monitored for comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the start of radiation therapy until 2 weeks after completion of treatment (approximately 8 weeks)

Collaborators and Investigators

• Sponsor: Christina Milad Lobos

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Antioxidants; Head and Neck Cancer; Quality of Life; Supportive Care; Dietary Supplement; Oral Mucositis; Rice Bran; Radiation-Induced Oral Mucositis; Radiation Therapy Side Effects; Cancer Treatment Support
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Stomatitis
• Other Study ID Numbers: RB-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No