Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

Conditions
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Breast, Radiotherapy, Aesthetics, Treatment Outcome, Surgical Reconstruction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer requiring mastectomy and post-mastectomy radiation Desire for breast reconstruction after mastectomy Exclusion Criteria: Inflammatory breast cancer Age < 18 years old No desire for breast reconstruction Women without need for postmastectomy radiation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

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 |
| --- | --- |
| 1<br>Immediate reconstruction followed by radiation therapy | |
| 2<br>Radiation therapy followed by delayed reconstruction | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic breast scores |  | preoperative, 1 month, 6 months, 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, Radiotherapy, Esthetics, Treatment Outcome, Reconstructive Surgical Procedures