Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Occurrence of radiodermatitis
研究概览
简要总结
It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the prevention of radiodermatitis in patients with breast cancer or head and neck cancer undergoing radiotherapy.
Prophylactic Trial will consist of a control group and two experimental groups, namely control group (usual care), Experimental Group 01 (usual care + topical application of the gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based cream).
The doses used in the different compounds are being in test since february 2014 by a dose-response curve study, using 6 groups with three doses of urea cream and three doses of C. recutita gel.
The study will be conducted at the Center for High Complexity Oncology at University Hospital of Brasília (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly, according to established criteria to classify the effects of radiotherapy, which identifies grades 0, 1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group - RTOG. To evaluate the skin reaction will also be applied scale Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).
详细描述
It is considered that patients undergoing radiotherapy in use gel based on C. recutita or use of cream based urea three times a day, concomitant radiotherapy, would present the following hypotheses:
- Null: equal incidence and severity of radiodermatitis when compared to the control group (usual care);
- Alternative 1: low incidence and severity of radiodermatitis when compared to patients who comprised the control group (usual care).
- Alternative 2: lower incidence and severity of radiodermatitis between the experimental groups (urea and chamomile).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Being an adult, over the age of 18 years old;
- •Owning diagnosis of malignant breast or head and neck;
- •Being first referred to the radiotherapy protocol;
- •Agree to participate, expressing his acceptance by signing the Informed Consent Form (ICF);
- •Present absence of dermatitis to initiation of radiotherapy;
- •Demonstrate understanding of and conditions to continue the intervention in their home environment when needed.
排除标准
- •Reports of previous hypersensitivity reaction or presentation, during the research, adverse reaction to chamomile or any plant of the Asteraceae or compositae family, or urea;
- •Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis;
- •Withdrawal of the patient to remain in the study, independent of time.
研究组 & 干预措施
1 Chamomilla recutita gel
Experimental Group 01: usual care + topical application of the gel recutita chamomile. Such intervention will be characterized by topical application of the gel C. recutita, concomitantly to the initiation of radiotherapy, should be applied on the irradiated three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).
干预措施: Chamomilla recutita gel (Other)
2 Urea cream
Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the area irradiated three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).
干预措施: Urea cream (Drug)
结局指标
主要结局
Occurrence of radiodermatitis
时间窗: 5 weeks
Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy).
次要结局
未报告次要终点
研究者
Elaine Barros Ferreira
Nurse
University of Brasilia