The Effect of RadiaAce Gel Versus Biafine in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- AceTech
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Patient's assessment of the skin condition (DLQI questioner)
研究概览
简要总结
Radiation dermatitis (RD) is one of the most common side effects of Radiation therapy (RT) and 95% of patients receiving RT may experience some form of radiation dermatitis.
A wide variety of topical, oral, and intravenous agents are used to prevent/treat Radiation dermatitis but currently there is no gold standard in the prevention and management of this condition and no treatment can be explicitly recommended.
RadiaAce Gel is a wound dressing Hydrogel (Acemannan Hydrogel) for the management of RD which provides optimal moist wound environment necessary to the healing process.
Based on its composition as well as the supporting data on safety and performance of the functional ingredient Acemannan in wound healing, RadiaAce may well be suited to complement the prevention and therapy of radiation dermatitis.
The primary aim of the study is to evaluate the safety and performance of RadiaAce as compare to Biafine in reducing the proportion of breast cancer patients that experience grade 2 or higher RD as measured by the RTOG scoring system
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Patients with histologically-confirmed diagnosis of breast cancer
- •Patients after breast lumpectomy and that scheduled to receive radiotherapy
- •Patients to receive minimum of 40.05 Gy to primary field
- •Must be able to comply with treatment schedule
- •Study-specific signed informed consent prior to randomization
排除标准
- •Inflammatory or connective tissue disorders of the skin
- •Mental incompetence, including psychological or addictive disorders which would preclude completion of questionnaires
- •Previous radiation therapy to the breast
- •Tumour involvement of the skin
- •Rash, ulceration or open wound in treatment field
- •Known skin allergy or sensitivity to Aloe Vera or Biafine
- •Current lactation
- •Any other reason that, in the opinion of the investigator, prevents the subject from
结局指标
主要结局
Patient's assessment of the skin condition (DLQI questioner)
时间窗: 10 weeks
The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)
Pain (VAS)
时间窗: 10 weeks
Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment
Skin assessment (RD grade)
时间窗: 10 weeks
Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring
次要结局
未报告次要终点