Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Aesthetic breast scores
研究概览
简要总结
This study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study.
The investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.
详细描述
Neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer treatment. (1, 2) Administration of radiation before or after autologous soft tissue reconstruction has being shown to alter the aesthetics of the new breast. (3-7) Currently, the optimal timing for autologous breast reconstruction in patients who need postmastectomy radiotherapy remains in debate between surgeons. (8) Various studies have tried to address this problem. However, most of them have been retrospective studies (3, 7, 9) and the prospective ones have not have enough patients, have mixed population of patients or the radiation protocols have not been normalized. (5, 6, 10)
We hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer requiring mastectomy and post-mastectomy radiation
- •Desire for breast reconstruction after mastectomy
排除标准
- •Inflammatory breast cancer
- •Age < 18 years old
- •No desire for breast reconstruction
- •Women without need for postmastectomy radiation
结局指标
主要结局
Aesthetic breast scores
时间窗: preoperative, 1 month, 6 months, 12 months, 24 months
次要结局
- Quality of life (SF36)(preoperative, 1 month, 6 months, 12 months, 24 months)
- Patient Breast aesthetic perception (BR23)(preoperative, 1 month, 6 months, 12 months, 24 months)