An interventional study of Citrus sinensis peel extract gel and Conventional supportive treatment in Radiation-induced Oral Mucositis and Head and Neck Cancer, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
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.
Radiotherapy is an important treatment modality for head and neck cancer, but radiation-induced oral mucositis is a frequent complication that may cause significant pain and interfere with oral function and quality of life.
This randomized controlled, single-blinded clinical trial will evaluate the efficacy of Citrus sinensis peel extract gel in the treatment of radiation-induced oral mucositis in head and neck cancer patients.
A total of 30 eligible patients will be randomly allocated into two parallel groups of 15 participants each. The experimental group will receive Citrus sinensis peel extract gel containing 5% w/w ethanolic Citrus sinensis peel extract. 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.
The control group will receive conventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed.
Clinical evaluation will be performed at baseline, 3 weeks, and 6 weeks. Pain intensity will be assessed using a Visual Analogue Scale (VAS), and oral mucositis severity will be assessed using the World Health Organization (WHO) oral toxicity scale. The Arabic version of the MD Anderson Symptom Inventory-Head and Neck module (MDASI-HN) will also be used to assess symptom burden. Clinical photographs will be obtained at the assessment time points.
Unstimulated saliva will be collected at baseline and 6 weeks to assess total antioxidant capacity using a validated colorimetric assay.
The study will be conducted at the Department of Oral Medicine, Faculty of Dentistry, Alexandria University, with recruitment from the outpatient clinic of the Department of Clinical Oncology, Faculty of Medicine, Alexandria University.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 30 is below the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
15 Participants will receive Citrus sinensis peel extract gel containing 5% w/w ethanolic Citrus sinensis peel extract. 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.
Drug: Citrus sinensis peel extract gel
Participants will receive conventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed.
Drug: Conventional supportive treatment
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 consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed.
Oral mucositis severity
Severity of radiation-induced oral mucositis assessed using the World Health Organization (WHO) oral toxicity scale. World Health Organization Oral Toxicity Scale is ranging from Grade 0 to Grade 4, where Grade 0 indicates no toxicity and Grade 4 represents the most severe toxicity. Higher grades indicate a worse outcome (greater severity of oral mucositis).
Time frame: Baseline, 3 weeks, and 6 weeks.
Pain intensity
Pain intensity measured using the Visual Analogue Scale (VAS). Pain intensity will be assessed using the Visual Analogue Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate a worse outcome (greater pain).
Time frame: Baseline, 3 weeks, and 6 weeks.
Salivary total antioxidant capacity
Total antioxidant capacity (TAC) measured in unstimulated saliva using a validated colorimetric assay.
Time frame: Baseline and 6 weeks.
Clinical photographic assessment
Clinical photographs documenting the appearance and severity of oral mucositis.
Time frame: Baseline, 3 weeks, and 6 weeks.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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