Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

Withdrawn

• Conditions: Treatment Outcome; Surgical Reconstruction; Aesthetics; Breast; Radiotherapy

• Registration Number: NCT00845078
• Lead Sponsor: University of Pittsburgh

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-12
• Status Verified: 2009-02
• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Breast cancer requiring mastectomy and post-mastectomy radiation
• Desire for breast reconstruction after mastectomy

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Exclusion Criteria

• Inflammatory breast cancer
• Age < 18 years old
• No desire for breast reconstruction
• Women without need for postmastectomy radiation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aesthetic breast scores	preoperative, 1 month, 6 months, 12 months, 24 months

Secondary Outcome Measures

Name	Time	Method
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