Rice bran for radiation-related mouth sores in head and neck cancer
Effects of Rice Bran on Radiation-Induced Oral Mucositis in Patients With Head/Neck Cancer and Its Impact on the Quality of Life
This trial will try rice bran supplements during radiation to see if adults with head and neck cancer have fewer or less severe mouth sores.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | German University in Cairo Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07242859 on ClinicalTrials.gov |
What this trial studies
Radiation-induced oral mucositis causes painful inflammation and ulcers in the mouths of many patients receiving radiation for head and neck cancer. This interventional trial gives rice bran supplements concurrently with IMRT to see whether the antioxidant and anti-inflammatory components reduce the incidence, duration, or severity of mucositis. Outcomes include clinical mucositis measures and patient-reported quality of life during and after radiation. The goal is to determine whether a low-cost dietary supplement can improve supportive care for these patients.
Who should consider this trial
Good fit: Adults aged 18 or older with non-metastatic head and neck squamous cell carcinoma scheduled for IMRT (radical or adjuvant) with ECOG 0–2, with or without concurrent chemotherapy, who can provide written consent are eligible.
Not a fit: Patients who are pregnant or breastfeeding, have oral lesions unrelated to their cancer or treatment, are taking drugs that cause oral lesions or anticoagulants, or are receiving other unapproved investigational anticancer agents are unlikely to benefit from this intervention in the trial.
Why it matters
Potential benefit: If successful, rice bran could offer a low-cost, accessible way to reduce the severity and duration of radiation-induced oral mucositis and improve patients' ability to eat and speak during treatment.
How similar studies have performed: Some antioxidant or anti-inflammatory dietary supplements have shown mixed effects on radiation-induced mucositis, while rice bran specifically has limited clinical trial data and remains relatively untested in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo
- German university in cairo — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Christina Milad Lobos, Master
- Email: Krstina.Bqtr@pharm.aun.edu.eg
- Phone: +20 1005279101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.