ACTRN12621001366842招募中2 期
A phase II pilot study of the use of vaginal oestriol to prevent vaginal stenosis in patients treated with radiotherapy for gynaecological, rectal and anal malignancies.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
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
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1. confirmed diagnosis of gynaecological, rectal or anal cancer
- •2. received external beam radiotherapy, with curative intent to the pelvis, (both primary treatment and neo/adjuvant treatment) of at least 45 gray in 25 fractions, or equivalent
- •3. aged 18 years or older
- •4. able to read and write English, and give written, informed consent
- •5. able to complete quality of life instruments
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
排除标准
- •1. severe psychiatric, cognitive or physical disorder that would preclude them from inserting an applicator
- •2. receiving radiotherapy for recurrent disease
- •3. had estrogen receptor positive breast cancer within last 5 years
- •4. currently on hormone replacement therapy (HRT).Those patients who were previously on hormone replacement therapy can go into the study as long as they have ceased the HRT at least 4 weeks prior to entry into the study
研究者
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