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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Milad Lobos, Master | Contact | +20 1005279101 | Krstina.Bqtr@pharm.aun.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German university in cairo | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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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.
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