Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

April 25, 2017 updated by: University of Pittsburgh

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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Immediate reconstruction followed by radiation therapy
2 Radiation therapy followed by delayed reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Aesthetic breast scores Time Frame: preoperative, 1 month, 6 months, 12 months, 24 months	preoperative, 1 month, 6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life (SF36) Time Frame: preoperative, 1 month, 6 months, 12 months, 24 months	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	preoperative, 1 month, 6 months, 12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

Principal Investigator: Julio A Clavijo-Alvarez, MD, University of Pittsburgh
Study Director: Michael L Gimbel, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria