ACTRN12607000100493已完成3 期
Trans Tasman Radiation Oncology Group (TROG) 04.01 - A paired double blind randomised comparison of Cavilon TM Durable Barrier Cream TM (CDBC) to 10% Glycerine ('Sorbolene') Cream in the prophylactic management of post-mastectomy irradiation skin care to reduce overall skin reactions.
Peter Graham0 个研究点目标入组 300 人开始时间: 2004年7月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Age 18 or more years. No upper limit.2. Post total mastectomy. Timing is not of relevance to this study therefore no limit.3. Planned dose at least 45 Gy in 25 fractions.4. Eastern Co-operative Oncology Group (ECOG) 0-2.5. Able to attend weekly during treatment for review and photo and up to 6 weeks after radiotherpay if reaction does not resolve prior.6. Patients capable of childbearing using adequate contraception.7. written informed consent.
排除标准
- •Exclusion:1. previous radiotherapy to the chest wall to be treated, either as definitive treatment or as entry/exit dose from previuos intra-thoracic malignancy radiotherapy.2. Macroscopic cutaneous involvement by malignancy at time of radiotherapy.3. patients who are pregnant or lactating4. known allergy to product contents
研究者
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