Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center Prospective Observational Trial Investigating the Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Immediate Breast reconstruction
* Procedure: Delayed Breast Reconstruction
* Radiation: Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BR group<br>Breast reconstruction without radiation therapy | Procedure: Immediate Breast reconstruction<br>* Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer<br>Procedure: Delayed Breast Reconstruction<br>* Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer<br>|
| Immediate BR +post-op radiation<br>Immediate breast reconstruction followed by surgical site radiation therapy | Procedure: Immediate Breast reconstruction<br>* Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer<br>Radiation: Radiation<br>* Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy<br>|
| Radiation +delayed BR<br>previous post-mastectomy radiation followed by delayed breast reconstruction | Procedure: Delayed Breast Reconstruction<br>* Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer<br>Radiation: Radiation<br>* Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of short term complications | 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 | the short term complications will be inspected up to 3 months post-op; | 
| occurrence and change of long term complications | 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. | 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 | 
| occurrence of secondary surgery | 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. | up to 24 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of revision surgery | any surgery performed to the reconstructed or contralateral breast to optimize symmetry | 6 to 24 months post-op | 
| baseline and change of subjective evaluation | patient oriented aesthetic, psychological and overall outcome evaluations are made with BREAST-Q (short for breast-questionnaire) post reconstruction module, the the selected questionnaire includes a set of questions regarding : category 1-patients' satisfaction with breasts; category 2-patients' satisfaction with outcome and category 3-patients' psychological well-being. In each category, the total score is generated by Q-score (short for questionnaire-score)software and the total score ranges from 0-100. The higher the score the better the satisfaction. | the baseline evaluation will be made at 6 months post-op; repeated evaluations will be made at 12 and 24 months to record changes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reconstruction, Chinese, radiation, timing