Effectivenes and Safety of a Cream of Aloe Vera, Camomila and Tomillo (Alantel) for Profilaxis or Treatmment of Deratitis by Radiotheraphy in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Incidence of radiation-induced dermatitis
研究概览
简要总结
It is intended to evaluate the effect of a marketed cream (Alantel®) based on natural products at high concentrations for the preventive and curative treatment (early stages) of radiation-induced dermatitis in cancer patients. For this, an experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicentre, will be carried out in which doctors will recruit 78 patients aged 14 years or over in Primary Care consultations. more, diagnosed with cancer, and having received radiotherapeutic cancer treatment, being randomly assigned to the experimental group (cosmetic cream) or the control group (emollient and moisturizing cream). The main variable will be the incidence rate of mild post-translational dermatitis and its improvement or cure once it has been established.
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
- Double (Participant, Care Provider)
盲法说明
Double blind: both the patient and the healthcare professional do not know if the cream to be tested or the placebo is applied
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 14 years of age or older
- •Diagnosed with cancer and who are or have recently received radiotherapy treatment.
- •We will include patients without dermatitis or with acute dermal posttradiotherapy lesions, in grades 1 and 2.
排除标准
- •Patients with dermal lesions in grade greater than
- •Skin cancer invasion or distant tumor metastasis.
- •Concurrent chemotherapy with RT, severe / extensive burns, moisture, erosion or suppuration in the skin, history of connective tissue disorders, severe mental disorder (dementia, drug addiction, etc.).
- •History of hypersensitivity reaction to any of the ingredients of the studio cream.
- •Participants involved in other clinical trials within that month.
研究组 & 干预措施
Intervention group
Local administration of the Alantel (R) cream on the affected skin
干预措施: Cosmetic cream (Alantel (R): aloe vera, chamomile and thime) (Combination Product)
Control group
Local administration of the Placebo cream on the affected skin
干预措施: Usual treatment (Combination Product)
结局指标
主要结局
Incidence of radiation-induced dermatitis
时间窗: three weeks
Analog visual scale
时间窗: three weeks
Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..)
次要结局
未报告次要终点
研究者
Luis A Perula
Clinical Professor
Hospital Universitario Reina Sofia de Cordoba