NCT01824134已完成3 期
A Phase III Double Blind Study on the Efficacy of Topical Aloe Vera Gel on Irradiated Breast Tissue
John D. Archbold Memorial Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- erythema
研究概览
简要总结
The investigators are testing two over the counter aloe veras on irradiated breast tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Women over 18 years of age who had undergone lumpectomy or partial mastectomy for breast cancer, and who then received postoperative radiation therapy using tangential fields, with or without a boost to the tumor bed. Chemotherapy as part of the treatment regimen was acceptable.
- •No major medical or psychiatric illness that might interfere with patient's completion of study requirements
- •Signed study-specific informed consent form prior to study entry
排除标准
- •Those requiring nodal radiation therapy were excluded.
- •Subjects who have a breast infection at the commencement of radiation treatment
- •Before randomization, subjects who have agreed to participate are asked if they are allergic to any topical preparation. Those allergic to aloe vera were ineligible.
研究组 & 干预措施
Klean & Klear
Active Comparator
aloe vera gel
干预措施: Klean & Klear The Dandy Day Corp (Other)
The Skin Gel
Active Comparator
aloe vera gel
干预措施: The Skin Gel Herbal Answers, Inc (Other)
结局指标
主要结局
erythema
时间窗: one year
since we are testing two over the counter products we wanted to wee if one tested better than the other
次要结局
- itching(one year)
研究者
J. Steven Johnson, MD
J. Steven Johnson, MD
John D. Archbold Memorial Hospital
研究点 (1)
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