Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Radiation-induced Oral Mucositis (Randomized Clinical Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- to compere the effect of Aloe vera mouth gel versus benzydamine mouth gel In the Management of pain and progression of Toxicity grading of oral mucositis according to World Health Organization (WHO) and National Cancer Institute Common Toxicity Criteria
研究概览
简要总结
Oral mucositis, a painful inflammation and ulceration of the mucous membranes in the mouth, is commonly seen in patients undergoing chemotherapy or radiation therapy. Effective management of this condition is crucial to reduce pain, promote healing, and maintain oral function.
Benzydamine mouth gel is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties, making it useful in treating oral mucositis. It works by blocking pain and reducing inflammation, helping to relieve symptoms like soreness and swelling. Studies suggest that benzydamine gel can decrease the severity of mucositis, ease discomfort, and improve patients' quality of life.
Aloe vera gel is well-known for its soothing, anti-inflammatory, and wound-healing properties. When applied to oral mucositis lesions, it promotes healing by providing hydration and forming a protective barrier over the affected tissue. Aloe vera's natural compounds, such as glycoproteins and polysaccharides, help in pain relief and accelerate tissue repair, making it a complementary option to reduce mucositis severity.
Together, benzydamine and aloe vera gels can be effective in managing oral mucositis. Benzydamine offers immediate pain relief and reduces inflammation, while aloe vera aids in longer-term healing and tissue regeneration. This combination approach has shown promise in enhancing comfort and accelerating recovery for patients with mucositis.
详细描述
Head and neck cancer (HNC) is a broad term, including epithelial malignancies that occur in the paranasal sinuses, nasal cavity, oral cavity, pharynx, and larynx. Almost all these malignancies are head and neck squamous cell carcinoma (HNSCC).
HNSCC is the sixth most common cancer worldwide, with 890,000 new cases and 450,000 deaths in 2018. The principal modalities of curative therapy for locally or locoregionally confined HNSCC are resection, radiation and systemic therapy. Treatment planning should aim for the most highly curative approach, while optimizing preservation of function
Head and neck cancers (HNC) are often treated with radiation therapy (RT), a technique that utilizes ionizing radiation and exerts therapeutic effect by semi-selectively damaging the genetic material of vulnerable malignant cells, either directly or through the production of free radicals, resulting in cell death.
Radiation-induced oral mucositis (RIOM) is one of the major ionizing radiation toxicities and normal tissue injuries that result from radiotherapy. RIOM is a normal tissue injury lasting between 7 and 98 days, which starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.
Oral mucositis is defined as inflammation of oral mucosa resulting from cancer therapy typically manifesting as atrophy, swelling, erythema and ulceration. The condition may be exacerbated by local factors, such as trauma from teeth, or microbial colonization. The term stomatitis refers to any inflammatory condition of oral tissue, including mucosa, dentition/periapices, and periodontium. Stomatitis thus defines a broader range of pathoses of oral tissues, including mucositis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed by head and neck cancer indicated for radiotheraby treatment
- •Adult age range from 20-55 male and female patients.
- •The patients had receiving a total external-beam RT dose of at least 50 Gy in standard fractions where the oral cavity had been exposed to RT.
- •The Karnovsky performance status was more than 70%.
- •Must be able to diffuse gel on oral cavity
排除标准
- •Food allergy.
- •Hypersensitivity to benzydamine or typical nonsteroidal anti-inflammatory drugs (NSAIDs).
- •Patients who had an existing lesion in the oral cavity (e.g. active infection or ulcer) before staring RT, or those who were unwilling to participate.
- •immunedifictincy desease
研究组 & 干预措施
benzydamine hydrochloride mouth gel
found that benzydamine mouth rinses and gels could prevent or reduce the severity of oral mucositis.
干预措施: Benzydamine Hydrochloride 0.15% Oral gel (Drug)
aloe vera gel
干预措施: Aloe vera gel (Drug)
bioadhesive gel
. They incorporate biodegradable mucoadhesive polymers to enhance retention on active mucosal surfaces and regulate the release of the drug
干预措施: Aloe vera gel (Drug)
bioadhesive gel
. They incorporate biodegradable mucoadhesive polymers to enhance retention on active mucosal surfaces and regulate the release of the drug
干预措施: bioadhesive gel (Drug)
结局指标
主要结局
to compere the effect of Aloe vera mouth gel versus benzydamine mouth gel In the Management of pain and progression of Toxicity grading of oral mucositis according to World Health Organization (WHO) and National Cancer Institute Common Toxicity Criteria
时间窗: from begining of radiation theraby at baseline and for 6 week ,once every one week
A complete oral examination will be performed within 24 hours of the first dose of study medication and at each visit. Oral areas at risk will be scored for the major signs of oral mucositis (i.e., erythema, pseudomembrane, and ulceration) -Grade 0: no sighns or symptoms * Grade 1(mild) Oral soreness, erythema of mucosa. * Grade 2 (moderate)Oral erythema, ulcers, Patchy pseudomembranous reaction (patches generally ≤1.5 cm in diameter and non-contiguous),but can eat or swallow. * Grade 3 (severe):Confluent pseudomembranous reaction (contiguous patches generally \>1.5 cm in diameter) requiring intravenous hydration. * Grade 4(life threatening): Necrosis or deep ulceration; may include bleeding not induced by minor trauma or abrasion.
次要结局
未报告次要终点
研究者
Arwa Abdelrady Osman
resident
Minia University