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Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845078
First Posted: February 16, 2009
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pittsburgh
  Purpose

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
Breast Radiotherapy Aesthetics Treatment Outcome Surgical Reconstruction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Aesthetic breast scores [ Time Frame: preoperative, 1 month, 6 months, 12 months, 24 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: December 2008
Groups/Cohorts
1
Immediate reconstruction followed by radiation therapy
2
Radiation therapy followed by delayed reconstruction

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing mastectomy and radiation for breast cancer, who desire breast reconstruction after mastectomy
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


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
  More Information