Evaluation of Therapeutic Efficacy in Use of Chamomila Gel, Chamomila Infuse and Urea in Patients With Breast or Head and Neck Cancer That Developed Radiodermatitis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 主要终点
- Reduction of the severity of radiodermatitis, according to the RTOG score.
研究概览
简要总结
This study aims to evaluate therapeutics interventions in radiodermatitis in patients with breast or head and neck cancer. The data collect is going to begin after determining the better dose in a dose-response curve that is being conduct now in the same institution. To evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).
详细描述
Hypothesis
Chamomila gel is more effective than urea (usual care); Chamomila infuse is more effective than urea (usual care); Chamomila gel is more effective than chamomila infuse; Chamomila infuse is more effective than chamomila gel; Chamomila gel is as effective than urea (usual care); Chamomila infuse is as effective than urea (usual care); Chamomila gel is as effective than chamomila infuse; Chamomila infuse is as effective than chamomila gel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being an adult, over the age of 18 years old; Owning diagnosis of breast or head and neck cancer; Being first referred to the radiotherapy protocol; Presenting radiodermatitis grades 1 or 2, second RTOG score, in the place where is receiving radiation therapy; No history of previous hypersensitivity reaction to chamomile or any plant of the Asteraceae or Compositae family or Urea; Demonstrate understanding to continue the intervention in their home environment when necessary.
排除标准
- •Medical prescription, during the process of data collection, some kind of intervention to prevent radiodermatitis
研究组 & 干预措施
Chamomila recutita Gel
Experimental Group 1 - patients will apply the gel since the begging of radiodermatitis, three times a day. The dose is being determined in a Phase II study that is being conducted. Topical application of gel is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.
干预措施: Chamomila recutita Gel (Other)
Chamomila recutita Infuse 2,5%
Experimental Group 2 - patients will apply the infuse since the begging of radiodermatitis, three times a day. The dose of 2,5% was determined before in a Phase II study. Radiodermatitis grade and intensity is going to be evaluated. Topical application of the infuse is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.
干预措施: Chamomila recutita Infuse (Other)
Urea cream based
Control Group - usual care to treat radiodermatitis, patients will apply the infuse since the begging of radiodermatitis, three times a day. Radiodermatitis grade and intensity is going to be evaluated. Topical application of urea is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.
干预措施: Urea cream based (Drug)
结局指标
主要结局
Reduction of the severity of radiodermatitis, according to the RTOG score.
时间窗: 5 weeks
This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score
次要结局
- Radiation Dose(5 weeks)
- Radiodermititis Cure(8 weeks)
- Time to reduce the severity of radiodermatitis(5 weeks)
研究者
PAULA ELAINE DINIZ DOS REIS
PROFESSOR
University of Brasilia