Body composition and outcomes after breast reconstruction

Investigation Into the Utility of Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction

This study will see if detailed body composition measurements can help predict complications after mastectomy with immediate breast reconstruction in adult women.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07546331 on ClinicalTrials.gov

What this trial studies

This observational study enrolls adults undergoing mastectomy with immediate reconstruction and collects body composition measurements alongside chart review, with participants followed for up to two years. Participants are assigned to one of two cohorts and undergo standardized body composition testing and routine clinical follow-up. The primary aim is to determine the feasibility of collecting these measurements; secondary aims compare body composition between those who develop reconstruction complications and those who do not and compare composition measures to standard anthropometric assessments. Analyses will look for associations between specific composition metrics and postoperative outcomes to inform risk stratification.

Who should consider this trial

Good fit: Ideal candidates are cisgender women age 18 or older with histologically confirmed or high-risk breast malignancy who are scheduled for mastectomy with immediate reconstruction using an implant, tissue expander, or autologous flap and can give informed consent.

Not a fit: Patients who are male at birth, non-cisgender women, pregnant or breastfeeding, have implanted electronic devices or prosthetic limbs, or have significant medical conditions that contraindicate participation are excluded and would not be expected to benefit from this study.

Why it matters

Potential benefit: If successful, the findings could help surgeons better predict which patients are at higher risk of reconstruction complications and tailor surgical planning or counseling.

How similar studies have performed: Similar work using CT- or bioimpedance-based body composition measures has shown associations with surgical complications in cancer and reconstructive settings, but results have been mixed and this specific application remains under study.

Eligibility criteria

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.

Where this trial is running

San Francisco, California

• University of California — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Merisas Piper, MD — University of California, San Francisco
• Study coordinator: Michael Choi

Conditions Breast Carcinoma; Breast Cancer; Postmastectomy breast reconstruction