Clinical trial · Interventional
Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
The Effect of Citrus Sinensis Peel Gel on Radiation-induced Oral Mucositis in Head and Neck Cancer Patients (Randomized Controlled Clinical Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiation-induced Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Citrus sinensis peel extract gel | Drug | — | UNRESOLVED |
| Conventional supportive treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Citrus sinensis Peel Gel
- description
- 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.
- interventionNames
- Drug: Citrus sinensis peel extract gel
- type
- ACTIVE_COMPARATOR
- label
- Conventional Treatment
- description
- 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.
- interventionNames
- Drug: Conventional supportive treatment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available