Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Immediate reconstruction followed by radiation therapy |
|
| 2 Radiation therapy followed by delayed reconstruction |
Outcome Measures
Primary Outcome Measures
- Aesthetic breast scores [preoperative, 1 month, 6 months, 12 months, 24 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Breast cancer requiring mastectomy and post-mastectomy radiation
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Desire for breast reconstruction after mastectomy
Exclusion Criteria:
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Inflammatory breast cancer
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Age < 18 years old
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No desire for breast reconstruction
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Women without need for postmastectomy radiation
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Pittsburgh
Investigators
- Principal Investigator: Julio A Clavijo-Alvarez, MD, University of Pittsburgh
- Study Director: Michael L Gimbel, MD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
- PRO07120002