RecruitingNot ApplicableNCT07242859

Rice Bran Supplementation for Radiation-Induced Oral Mucositis 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


Sponsor

Christina Milad Lobos

Enrollment

80 participants

Start Date

Jan 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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.


Locations(1)

German university in cairo

Cairo, Egypt

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NCT07242859


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