Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis

NCT07813923 | Not Yet Recruiting DMC

• 1 other identifier: 00010556 - IORG 0008839
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation-induced Oral Mucositis; Head and Neck Cancer

Keywords

Citrus sinensis; Oral mucositis; Head and neck cancer; Radiotherapy; Herbal therapy; Radiation; Herbal gel

Outcome Measures

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).

  Baseline, 3 weeks, and 6 weeks.

Secondary Outcomes (3)

• Pain intensity

  Baseline, 3 weeks, and 6 weeks.

• Salivary total antioxidant capacity

  Baseline and 6 weeks.

• Clinical photographic assessment

  Baseline, 3 weeks, and 6 weeks.

Study Arms (2)

Citrus sinensis Peel Gel

EXPERIMENTAL

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

Conventional Treatment

ACTIVE COMPARATOR

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

Interventions

Citrus sinensis peel extract gel DRUG

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.

Citrus sinensis Peel Gel

Conventional supportive treatment DRUG

Conventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic analgesics as needed.

Conventional Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.
• Patients who are clinically diagnosed with oral mucositis (WHO grade ≥1).

You may not qualify if:

• 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
• Patients allergic to orange
• Patients allergic to citrus peel or gel formulation components
• Patients with systemic diseases (e.g., hypertension, diabetes, cardic diseases etc.)
• Patients who have other oral lesions not related to mucositis (e.g., herpetic ulcers, candidiasis)

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

outpatient clinic of the Department of Clinical Oncology, Faculty of Medicine

Alexandria, Alexandria Governorate, 11553, Egypt

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Eglal Mohamed Moussa, Professor of Oral medicine

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rawan I Assy, Bachelor

CONTACT

+201090914664; Rawan.Asi.dent@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study will be a single-blinded controlled clinical trial where the oral medicine co-worker specialist who will evaluate the outcome of clinical intervention in the 2 groups will be blinded to the type of intervention used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated to one of two parallel groups: a Citrus sinensis peel extract gel group or a conventional supportive treatment group. Participants will receive their assigned intervention for 6 weeks, with clinical assessments performed at baseline, 3 weeks, and 6 weeks.

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

EG (1)