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临床试验/NCT02249884
NCT02249884已完成2 期

Use of Chamomilla Recutita Gel and Urea Cream to Prevent and Treat Radiodermatitis: Phase 2 Study

University of Brasilia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Time of occurrence of Radiodermatitis

研究概览

简要总结

Dose response curve to define the security and tolerable dose to be used for prevention and treatment of radiodermatitis in patients with breast or head and neck cancer.

详细描述

The study is being conducted in Center for High Complexity Oncology (CACON) located at the University Hospital of Brasília (HUB). Has as its target population subjects diagnosed with breast and head and neck cancer undergoing radiotherapy. Three doses of urea cream are being tested. Participants are subjected to simple randomization technique, in which the members of the study are directly allocated in groups set forth, without any intermediate step. Patients are identified, go to a nursing consultation for general orientations about treatment. After the consultation, patients are invited to participate in the study. The patient should express its acceptance through the informed consent form. Data are being collected through interviews and medical records. Patients are being evaluated during three weeks, considering the toxicity of the intervention and the beginning of radiodermatitis. 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). For reliable assessment and record of the evolution throughout the treatment and study, patients will be photographed weekly (D0, D5, D10, D15). Will be photographed major regions subject to evaluation: frontal, right side profile and left side profile with Photographic camera Nikon P510. The data will be inserted into Statistical Package for Social Sciences (SPSS), version 18.0, for the analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

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
  • Have absence of radiodermatitis and integrates skin to start radiotherapy
  • Not have presented anticipated reaction of hypersensitivity to chamomile or any plant of the family Asteraceae or Compositae or urea.
  • Demonstrate conditions to continue the intervention in their home environment when needed.

排除标准

  • Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis.

研究组 & 干预措施

Urea Dose A

Experimental

Topical application of the urea cream in concentration A. The product should be applied on the skin three times daily over 3 weeks.

干预措施: Urea Dose A (Drug)

Urea Dose B

Experimental

Topical application of the urea cream in concentration B. The product should be applied on the skin three times daily over 3 weeks.

干预措施: Urea Dose B (Drug)

Urea Dose C

Experimental

Topical application of the urea cream in concentration C. The product should be applied on the skin three times daily over 3 weeks.

干预措施: Urea Dose C (Drug)

Chamomile Dose A

Experimental

Topical application of chamomile recutita gel in concentration A. The product should be applied on the skin three times daily over 3 weeks.

干预措施: Chamomile Dose A (Drug)

Chamomile Dose B

Experimental

Topical application of chamomile recutita gel in concentration B. The product should be applied on the skin three times daily over 3 weeks.

干预措施: Chamomile Dose B (Drug)

Chamomile Dose C

Experimental

Topical application of chamomile recutita gel in concentration C. The product should be applied on the skin three times daily over 3 weeks.

干预措施: Chamomile Dose C (Drug)

结局指标

主要结局

Time of occurrence of Radiodermatitis

时间窗: 3 weeks

Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG).

次要结局

  • Indicators of toxicity(3 weeks)

研究者

发起方
University of Brasilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elaine Barros Ferreira

RN, University of Brasilia

University of Brasilia

研究点 (1)

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