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Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
Sponsor: Alexandria University
Summary
This randomized controlled clinical trial aims to evaluate the efficacy of Citrus sinensis peel extract gel in the treatment of radiation-induced oral mucositis in head and neck cancer patients. Thirty adult patients with head and neck cancer who develop oral mucositis during radiotherapy will be randomly allocated into two parallel groups. The intervention group will receive Citrus sinensis peel extract gel, while the control group will receive conventional supportive treatment. Clinical outcomes will be evaluated at baseline, 3 weeks, and 6 weeks, including pain intensity and severity of oral mucositis. Salivary total antioxidant capacity will be assessed at baseline and after 6 weeks.
Official title: THE EFFECT OF CITRUS SINENSIS PEEL GEL ON RADIATION-INDUCED ORAL MUCOSITIS IN HEAD AND NECK CANCER PATIENTS (RANDOMIZED CONTROLLED TRIAL)
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-10-01
Completion Date
2027-06-30
Last Updated
2026-09-10
Healthy Volunteers
No
Interventions
Citrus sinensis peel extract gel
Citrus sinensis peel extract gel containing 5% w/w ethanolic Citrus sinensis peel extract in a gel-forming polymer. The gel will be applied directly to the affected oral mucosa three times daily, preferably after meals and oral rinsing, for 6 weeks. Participants will be instructed to avoid eating or drinking for 30 minutes after application. In case of hypersensitivity, the intervention will be discontinued and the study team will be notified.
Conventional supportive treatment
Conventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed.
Locations (1)
outpatient clinic of the Department of Clinical Oncology, Faculty of Medicine
Alexandria, Alexandria Governorate, Egypt