Rice Bran Supplementation for Radiation-Induced Oral Mucositis in Head and Neck Cancer

NCT07242859 | Recruiting

• 1 other identifier: RB-2025-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiation-Induced Oral Mucositis; Head &Amp; Neck Cancer; Head &Amp; Neck Squamous Cell Carcinoma

Keywords

Radiation-Induced Oral Mucositis; Oral Mucositis; Head and Neck Cancer; Rice Bran; Dietary Supplement; Radiation Therapy Side Effects; Quality of Life; Supportive Care; Antioxidants; Cancer Treatment Support

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Rice Bran Supplement Group

EXPERIMENTAL

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

Control Group (Standard Care)

NO INTERVENTION

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.

Interventions

rice bran DIETARY_SUPPLEMENT

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.

Also known as: Oryza

Rice Bran Supplement Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christina Milad Lobos: lead

Study Sites (1)

German university in cairo

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Christina Milad Lobos, Master

CONTACT

+20 1005279101; Krstina.Bqtr@pharm.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator, Assistant Lecturer

Model Details: This is a parallel-group interventional study where participants are assigned to one of two groups. The active group receives rice bran supplements during radiation therapy, while the control group receives standard care without rice bran. The study compares the effects of rice bran on radiation-induced oral mucositis and quality of life between the two groups.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: January 15, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)