Skip to content

Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00845078
Enrollment
0
Registered
2009-02-16
Start date
2008-12-31
Completion date
Unknown
Last updated
2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aesthetics, Breast, Radiotherapy, Surgical Reconstruction, Treatment Outcome

Keywords

Breast, Radiotherapy, Esthetics, Treatment Outcome, Reconstructive Surgical Procedures

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.

Interventions

None listed

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Aesthetic breast scorespreoperative, 1 month, 6 months, 12 months, 24 months

Secondary

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026