Head and Neck Cancer, Radiation-induced Oral Mucositis
Conditions
Keywords
Citrus sinensis, Oral mucositis, Head and neck cancer, Radiotherapy, Herbal therapy, Radiation, Herbal gel
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.
Detailed description
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.
Interventions
DRUGCitrus 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.
DRUGConventional 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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral mucositis severity | Baseline, 3 weeks, and 6 weeks. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Baseline, 3 weeks, and 6 weeks. | 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). |
| Salivary total antioxidant capacity | Baseline and 6 weeks. | Total antioxidant capacity (TAC) measured in unstimulated saliva using a validated colorimetric assay. |
| Clinical photographic assessment | Baseline, 3 weeks, and 6 weeks. | Clinical photographs documenting the appearance and severity of oral mucositis. |
Countries
Egypt
Contacts
CONTACTRawan I Assy, Bachelor
PRINCIPAL_INVESTIGATOREglal Mohamed Moussa, Professor of Oral medicine
Alexandria University
Outcome results
None listed