Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Average of the radiation dermatitis intensity
研究概览
简要总结
Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.
详细描述
Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old or more
- •Patients with breast cancer for which a treatment by radiotherapy is planned
- •No concomitant chemotherapy
- •Signed informed consent
排除标准
- •Cutaneous neoplasia radiotherapy
- •Total mastectomy
- •Bilateral breast cancer
- •Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder
- •Pregnant, breast-feeding woman
研究组 & 干预措施
EVOSKIN
Patients are to apply Evoskin ( topical agent) in the half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day.
干预措施: Evoskin (Drug)
TRIXIERA
Patients are to apply Trixiera ( topical agent) in the other half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day.
干预措施: Trixiera (Drug)
结局指标
主要结局
Average of the radiation dermatitis intensity
时间窗: at 3 months
Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy
次要结局
- Clinical grade of dermatitis(at 3 months)