Head &Amp; Neck Cancer, Head &Amp; Neck Squamous Cell Carcinoma, Radiation-Induced Oral Mucositis
Conditions
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
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTrice 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.
Sponsors
Christina Milad Lobos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade ≥ 3 mucositis . | From the start of radiation therapy until 2 weeks after completion of treatment (approximately 8 weeks) | 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. |
Countries
Egypt
Contacts
Primary ContactChristina Milad Lobos, Master
Outcome results
None listed