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

Christina Milad Lobos

Status: Enrolling

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

Treatments: Dietary Supplement: rice bran

Study type: Interventional

Funder types: Other

Identifiers

NCT07242859

RB-2025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Rice Bran Supplement Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: rice bran

Control Group (Standard Care)

No Intervention group

Description:

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.