Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00845078|
Recruitment Status : Withdrawn
First Posted : February 16, 2009
Last Update Posted : April 27, 2017
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|
|Breast Radiotherapy Aesthetics Treatment Outcome Surgical Reconstruction|
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 Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer|
|Study Start Date :||December 2008|
Immediate reconstruction followed by radiation therapy
Radiation therapy followed by delayed reconstruction
- Aesthetic breast scores [ Time Frame: preoperative, 1 month, 6 months, 12 months, 24 months ]
- Quality of life (SF36) [ Time Frame: preoperative, 1 month, 6 months, 12 months, 24 months ]
- Patient Breast aesthetic perception (BR23) [ Time Frame: preoperative, 1 month, 6 months, 12 months, 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845078
|Principal Investigator:||Julio A Clavijo-Alvarez, MD||University of Pittsburgh|
|Study Director:||Michael L Gimbel, MD||University of Pittsburgh|