Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients Receiving Radiation Therapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- the mean Radiation Therapy Oncology Group (RTOG) skin dermatitis score
研究概览
简要总结
Radiation dermatitis is an acute effect of radiation therapy,Especially in the neck skin of head and neck squamous cell carcinomas' patients.The investigators wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study.
详细描述
A randomized,self-comparative controlled trial was undertaken comparing MF cream with no cream administered from the first day of treatment for 5-6 weeks to prevent radiation dermatitis of neck during radiation therapy to the head and neck squamous cell carcinomas' Patients.
One side of patients' neck will begin to use MF cream from the first day of radiation therapy, while the other side accept no preventive measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological diagnosis for head and neck squamous cell carcinomas and
- •going to have radiotherapy.
排除标准
- •pregnant,
- •lactating women,
- •elderly people with atrophy skin,
- •allergic constitution patients,
- •the corresponding parts of 5 radiotherapy skin ulceration or infection and
- •allergic patients to Mometasone Furoate Cream.
研究组 & 干预措施
Mometasone Furoate Cream(MF)
participants will be given conventional Chemoradiotherapy and MF.
MF Brief introduction:
Generic name :Mometasone Furoate Cream. Dosage form:Each gram of Mometasone Furoate Cream contains mometasone furoate, USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate, stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate, white wax, white petrolatum, and purified water.
Dosage:Apply a thin film of Mometasone Furoate Cream to the affected skin areas once daily during radiotherapy.
It is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
干预措施: Mometasone Furoate Cream (Drug)
结局指标
主要结局
the mean Radiation Therapy Oncology Group (RTOG) skin dermatitis score
时间窗: seven weeks
The investigators descriph the skin dermatitis scores every week during radiation therapy and the later two weeks as follows:The scores were 0 = no visible change; 1 = faint or dull erythema; 2 = tender or bright erythema with or without moist desquamation; 3 = patchy moist desquamation with moderate edema; and 4= confluent moist desquamation with pitting edema.
次要结局
未报告次要终点
研究者
Yao Liao
Doctor of oncology department in Mianyang Central Hospital
Mianyang Central Hospital