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

NCT ID: NCT07242859

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

rice bran

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Oryza

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christina Milad Lobos

OTHER

Sponsor Role lead

Responsible Party

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Christina Milad Lobos

Sponsor-Investigator, Assistant Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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German university in cairo

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Christina Milad Lobos, Master

Role: CONTACT

+20 1005279101

Other Identifiers

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RB-2025-01

Identifier Type: -

Identifier Source: org_study_id

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