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Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00845078
First received: February 13, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (SF36) [ Time Frame: preoperative, 1 month, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Patient Breast aesthetic perception (BR23) [ Time Frame: preoperative, 1 month, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845078

Contacts
Contact: Julio A Clavijo-alvarez, MD, PhD 412 6575588 clavja@upmc.edu
Contact: Michael L Gimbel, MD 4126615380 gimbelml@upmc.edu

Locations
United States, Pennsylvania
Magee Women's Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Julio A Clavijo-Alvarez, MD, PhD     412-657-5588     clavja@upmc.edu    
Contact: Michael L Gimbel, MD     4126615380     Gimbelml@upmc.edu    
Principal Investigator: Julio A. Clavijo-Alvarez, MD            
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

Publications:

Responsible Party: Julio A. Clavijo-Alvarez/ MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00845078     History of Changes
Other Study ID Numbers: PRO07120002
Study First Received: February 13, 2009
Last Updated: February 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Breast
Radiotherapy
Esthetics
Treatment Outcome
Reconstructive Surgical Procedures

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013