A Multicentre Randomized Controlled Clinical Trial for the Reduction of Acute Skin Reaction in Adjuvant Breast Radiation in Large Breasted Women Using a Prone Technique - The Prone Breast Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 378
- 试验地点
- 4
- 主要终点
- Moist Desquamation
研究概览
简要总结
Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size.
After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life.
This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.
详细描述
The risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. Evidence suggests that the use of a prone breast IMRT technique has the potential to decrease the risk of moist desquamation in large breasted women to the levels that are now seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes of providing motivation for this study, a multicentre RCT is feasible to confirm and quantify the improvement provided by the prone technique and provide Level 1 evidence for it to be adopted world-wide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (DCIS);
- •treated with BCT;
- •no indication for treatment of regional LN;
- •Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or greater
排除标准
- •Regional Lymph Node XRT indicated;
- •Bilateral breast cancer;
- •unhealed wound (skin not closed and/or infection);
- •previous XRT to the same breast;
- •unable to lie prone;
- •presence of active connective tissue disease;
- •pregnancy;
- •unacceptable heart exposure (as measured by > 10% of the heart receiving 50% of the prescribed dose, i.e. V25Gy > 10%);
- •adequate coverage of postoperative tumour bed not technically possible
研究组 & 干预措施
RT Positioning Intervention: Supine
Patient will be treated in a supine position as per standard of care/control.
干预措施: Radiation Therapy Positioning Intervention (Radiation)
RT Positioning Intervention: Prone
Patient will be treated in the prone position.
干预措施: Radiation Therapy Positioning Intervention (Radiation)
结局指标
主要结局
Moist Desquamation
时间窗: 6-8 week post-treatment.
Acute moist desquamation rates as measured by CTCAE 4.03 during and up to 6-8 weeks post treatment.
次要结局
- Breast Pain(6-8 week post-treatment.)
- Radiation exposure of adjacent normal organs at risk(Day 1)
研究者
Danny Vesprini, MD, MSc, FRCPC
Radiation Oncologist
Toronto Sunnybrook Regional Cancer Centre