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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

February 13, 2009
February 13, 2009
December 2008
Not Provided
Aesthetic breast scores [ Time Frame: preoperative, 1 month, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients undergoing mastectomy and radiation for breast cancer, who desire breast reconstruction after mastectomy

  • Breast
  • Radiotherapy
  • Aesthetics
  • Treatment Outcome
  • Surgical Reconstruction
Not Provided
  • 1
    Immediate reconstruction followed by radiation therapy
  • 2
    Radiation therapy followed by delayed reconstruction

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
Not Provided
Not Provided

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
Female
18 Years to 70 Years
No
Contact: Julio A Clavijo-alvarez, MD, PhD 412 6575588 clavja@upmc.edu
Contact: Michael L Gimbel, MD 4126615380 gimbelml@upmc.edu
United States
 
NCT00845078
PRO07120002
No
Julio A. Clavijo-Alvarez/ MD, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Julio A Clavijo-Alvarez, MD University of Pittsburgh
Study Director: Michael L Gimbel, MD University of Pittsburgh
University of Pittsburgh
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP