Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorAlexandria University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing radiotherapy for head and neck cancer as postoperative (adjuvant) therapy or definitive therapy.
Patients between 18-50 years.
Both males and females.
Patients whose radiotherapy treatment planned dose is 50 Gy or above 8
Disqualifiers
Smokers, due to impaired mucosal healing and increased inflammation
Pregnant and lactating women
Patients with poor oral hygiene
Use of systemic or topical mucositis treatments within the past 7 days
Trial design
Design model
Parallel
Treatments tested in this trial
Citrus sinensis peel extract gel
DrugCitrus 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
DrugConventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Citrus sinensis Peel GelExperimental treatment 1 intervention
Group B: Conventional TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
Salivary total antioxidant capacity
Total antioxidant capacity (TAC) measured in unstimulated saliva using a validated colorimetric assay.
Time frame
Baseline and 6 weeks.3
Clinical photographic assessment
Clinical photographs documenting the appearance and severity of oral mucositis.
Time frame
Baseline, 3 weeks, and 6 weeks.Sponsors and contacts
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Source ClinicalTrials.gov
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