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Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer


N/A
18 Years
70 Years
Open (Enrolling)
Female
Breast, Radiotherapy, Aesthetics, Treatment Outcome, Surgical Reconstruction

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Trial Information

Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Aesthetic breast scores

Outcome Time Frame:

preoperative, 1 month, 6 months, 12 months, 24 months

Safety Issue:

No

Principal Investigator

Julio A Clavijo-Alvarez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

PRO07120002

NCT ID:

NCT00845078

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Breast
  • Radiotherapy
  • Aesthetics
  • Treatment Outcome
  • Surgical Reconstruction
  • Breast
  • Radiotherapy
  • Esthetics
  • Treatment Outcome
  • Reconstructive Surgical Procedures
  • Breast Neoplasms

Name

Location

Magee Women's Hospital Pittsburgh, Pennsylvania  15213