A Multi-center Prospective Observational Trial Investigating the Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 1,344
- 主要终点
- occurrence of short term complications
研究概览
简要总结
The purpose of the study is to investigate the impacts of radiation and the timing of radiation on autologous and prosthetic-based breast reconstruction in Chinese post-mastectomy breast cancer patients. The study aims to optimize the timing for autologous/prosthetic breast reconstruction which delivers the best aesthetic results while maintains low complication rate and best integrates into the comprehensive breast cancer treatment. The study is open to all female breast cancer patients undergoing breast reconstruction in the department of breast reconstruction in Tianjin medical university cancer institute and hospital.
详细描述
In breast cancer patients, post-operative radiation therapy is an important component in breast cancer management. However, in the context of breast reconstruction, radiation can have adverse effect as it increases the rate of fat necrosis and leads to fibrosis/ capsular contracture in the reconstructed breast mounds. It is therefore necessary to investigate the best timing for breast reconstruction, especially in those patients which post-operative radiation is required, which does not interfere with overall breast cancer treatment while produces the best surgical, aesthetic and psychological outcome. Most studies in this field are retrospective, and studies on Chinese cohort are also rare. This multi-center prospectively designed clinical trial will include several medical centers across China. The investigators will allocate the patients into three arms based on the status and sequence of radiation and breast reconstruction, and will further stratify the groups based on the different approaches of reconstruction (autologous/ prosthetic based). Both objective and subjective (patient oriented) methods will be employed to make evaluations involving surgical, aesthetic, and psychological outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with breast cancer
- •Karnofsky Performance Status (KPS) larger than 70
- •Underwent autologous or prosthetic based breast reconstruction
- •No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
排除标准
- •Metastatic breast cancer
- •Local recurrence after mastectomy
- •Prior radiation history to chest wall due to other tumors
- •Radiation performed more than 6 months after mastectomy
- •Interruption of radiation more than 2 weeks
- •Gravida or during lactation
- •Concurrently undergoing psychotic disorders
结局指标
主要结局
occurrence of short term complications
时间窗: the short term complications will be inspected up to 3 months post-op;
impaired arterial or venous flap perfusion by increased (\>3 seconds) or reduced (\<2 seconds) capillary refill time; infection of the reconstructed breast with evidences from microbiological cultures; partial or entire flap necrosis with evident demarcation by clinical observation
occurrence of secondary surgery
时间窗: up to 24 months post-op
unplanned surgery due to short-term and/or long-term complications post-op, the types of secondary surgery include but not limited to exploratory surgery, flap salvages, removal or fat necrosis, debridement, prosthetic explantation.
occurrence and change of long term complications
时间窗: the long term complications will be assessed at 6 months post-op; repeated assessments will be made at 12 and 24 months to record changes
fat necrosis proven by breast ultrasound/ breast MRI/ pathology; flap contracture that causes change in shape and/or volume in the reconstructed breast mound observed by naked-eye inspection or breast imaging; capsular contracture that causes hardness/pains or changes of the reconstructed breast mound observed by surgeon's inspection or breast imaging.
次要结局
- baseline and change of subjective evaluation(the baseline evaluation will be made at 6 months post-op; repeated evaluations will be made at 12 and 24 months to record changes)
- occurrence of revision surgery(6 to 24 months post-op)