The Effect of Citrus Sinensis Peel Gel on Radiation-induced Oral Mucositis in Head and Neck Cancer Patients (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Oral mucositis severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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)
研究组 & 干预措施
Citrus sinensis Peel Gel
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.
干预措施: Citrus sinensis peel extract gel (Drug)
Conventional Treatment
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.
干预措施: Conventional supportive treatment (Drug)
结局指标
主要结局
Oral mucositis severity
时间窗: 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).
次要结局
- Salivary total antioxidant capacity(Baseline and 6 weeks.)
- Clinical photographic assessment(Baseline, 3 weeks, and 6 weeks.)
- Pain intensity(Baseline, 3 weeks, and 6 weeks.)