Rice Bran Supplementation for Radiation-Induced Oral Mucositis in Head and Neck Cancer
NCT ID: NCT07242859
Last Updated: 2025-11-21
Study Results
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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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-01-15
2025-12-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Christina Milad Lobos
OTHER
Responsible Party
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Christina Milad Lobos
Sponsor-Investigator, Assistant Lecturer
Locations
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German university in cairo
Cairo, , Egypt
Countries
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Central Contacts
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Other Identifiers
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RB-2025-01
Identifier Type: -
Identifier Source: org_study_id
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