Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction

Purpose

This study compares measurements of body composition to outcomes of breast reconstruction.

Conditions

  • Breast Carcinoma
  • Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Patients must have histologically confirmed breast malignancy or increased risk of developing a breast malignancy. 2. Age ≥ 18 years. 3. Scheduled to undergo mastectomy with immediate breast reconstruction using a permanent implant, tissue expander, or autologous tissue (e.g. Deep Inferior Epigastric Perforator (DIEP) flap, muscle-sparing Transverse Rectus Abdominis Myocutaneous (msTRAM) flap, Profunda Artery Perforator (PAP) flap). 4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

  1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 2. Pregnant or breastfeeding. 3. Patients assigned male at birth. 4. Non-cisgender women. 5. Patients with implanted electronic medical devices (e.g. pacemaker, defibrillator). 6. Patients with prosthetic limbs.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cohort A: Implant-based Reconstruction Patients undergo standard of care implant-based breast reconstruction and body composition measurement on study.
  • Procedure: Measurement of Body Composition
    Body composition measurements collected pre and post operatively using a bioelectrical impedance analyzer.
  • Other: Chart Review
    Clinical and surgical data will be collected from the participants medical records.
Cohort B: Autologous Reconstruction Patients undergo standard of care autologous breast reconstruction and body composition measurement on study.
  • Procedure: Measurement of Body Composition
    Body composition measurements collected pre and post operatively using a bioelectrical impedance analyzer.
  • Other: Chart Review
    Clinical and surgical data will be collected from the participants medical records.

Recruiting Locations

University of California
San Francisco, California 94143
Contact:
Michael Choi
877-827-3222
Michael.Choi@ucsf.edu

More Details

Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

Michael Choi
877-827-3222
Michael.Choi@ucsf.edu

Detailed Description

PRIMARY OBJECTIVES: 1. Determine feasibility of collecting measurements of body composition. SECONDARY OBJECTIVES: 1. Define the differences in body composition between participants undergoing breast reconstruction who develop complications and those who do not. 2. To determine the implications of different measures of body composition on outcomes of breast reconstruction. 3. Compare utility of body composition measurements versus other anthropometric assessments on assessing risk of complications following breast surgery. OUTLINE: This is a observational study. Participants are assigned to 1 of 2 cohorts and will be follow-up for up to 2 years.