Fat Grafting for Breast Reconstruction

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Unwilling to participate

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines changes in breast skin blood supply after radiation therapy and fat grafting in women who have undergone a mastectomy. The researchers aim to determine if adding fat to the breast improves blood flow. Participants are divided into two groups: one will receive fat grafting, and the other will not. Women who have had breast cancer, a mastectomy, and require radiation therapy as part of their reconstruction may be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to contribute to the understanding of innovative reconstruction techniques.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that fat grafting is safe for breast reconstruction?

Research has shown that fat grafting for breast reconstruction is safe. Studies have found no increased risk of death from this procedure. Fat grafting is considered a safe and effective option, using the patient's own tissue to improve quality of life.

One study found that patients who underwent fat grafting had a lower risk of death compared to those who did not. Another study confirmed that fat grafting did not affect important measures like overall survival or disease-free survival.

In summary, current evidence suggests that fat grafting is well-tolerated and does not pose significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fat grafting for breast reconstruction is unique because it uses a patient's own fat to reconstruct the breast, offering a more natural look and feel compared to traditional implants. This technique is less invasive and can be more personalized, as the fat is harvested from other areas of the patient's body, potentially improving body contour in those areas as well. Researchers are excited because fat grafting may reduce the risk of complications often associated with synthetic implants, such as capsular contracture, and it eliminates the need for foreign materials in the body.

What evidence suggests that fat grafting is effective for breast reconstruction?

Research shows that fat grafting is a popular and effective method for breast reconstruction. In this trial, some participants will undergo breast reconstruction with fat grafting, using their own fat tissue, known as autologous fat transfer (AFT). Studies have found this to be a safe option with good results. A high percentage of patients, 94.3%, report satisfaction with their outcomes, and plastic surgeons report a satisfaction rate of 95.7%. Additionally, MRI scans and patient feedback confirm positive results for those who have had the procedure. Overall, fat grafting in breast reconstruction has shown promising success in improving breast appearance after a mastectomy. ^{4 6 7 8 9}

Who Is on the Research Team?

Christin A. Harless, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for breast cancer patients who have had a mastectomy and are undergoing immediate reconstruction with tissue expanders or implants that require radiation therapy. It's not open to those who do not wish to participate.

Inclusion Criteria

I am a breast cancer patient getting an implant or tissue expander with planned radiation therapy.

I have had a mastectomy.

Exclusion Criteria

I am willing to participate in the clinical trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo radiation therapy as part of their post-mastectomy treatment

6-8 weeks

Fat Grafting

Participants receive autologous fat transfer to the breast(s) to improve skin perfusion

1-2 weeks

Follow-up

Participants are monitored for radiation fibrosis and skin perfusion changes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Fat Grafting

Trial Overview

The study is looking at how well blood flows through the skin of the breast after it has been treated with radiation and then fat grafting. This will help understand if fat grafting improves skin condition post-radiation.

How Is the Trial Designed?

Group I: Breast reconstruction with fat grafting Experimental Treatment 1 Intervention

fat grafting

Group II: breast reconstruction without fat grafting Active Control 1 Intervention

No Fat grafting

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8033056/

Oncological outcomes of lipofilling in breast reconstruction

Fat grafting is a procedure commonly used in breast reconstruction nowadays. Nevertheless, its oncological safety remains controversial.

2.

jamanetwork.com

jamanetwork.com/journals/jamasurgery/fullarticle/2802106

Effect of Total Breast Reconstruction With Autologous Fat ...

The findings of this study indicate that AFT offers patients with breast cancer an effective and safe option breast reconstruction that uses their own tissue ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352320424001858

Autologous fat grafting for postoperative breast reconstruction

Multiple studies have confirmed that pre-expansion with BRAVA can accommodate large-volume fat grafting while improving graft survival rates [15,16]. However, ...

4.

journals.lww.com

journals.lww.com/plasreconsurg/fulltext/2023/09000/total_breast_reconstruction_with_lipofilling_after.2.aspx

Total Breast Reconstruction with Lipofilling after Traditional

Here, we presented MRI imaging and patient-reported outcomes data for 38 women with 41 breasts who underwent reconstruction with lipofilling.

5.

academic.oup.com

academic.oup.com/asj/article/41/Supplement_1/S50/6277491

Assessing Clinical Outcomes in Autologous Fat Grafting

This study demonstrated an overall patient satisfaction rate of 94.3% and plastic surgeon satisfaction rate of 95.7% after follow-up of 1.9 and ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38117044/

Oncological Safety of Autologous Fat Grafting for Breast ...

There was no increased risk of all-cause mortality after fat grafting for breast reconstruction (3.9% fat-grafted vs 6.6% non-fat-grafted, P = ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1748681525003584

Preliminary data on the oncological safety of autologous fat ...

Findings from the BREAST trial demonstrated that AFT is a minimally invasive, effective, and safe option, with superior quality of life outcomes compared to ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40652913/

Preliminary data on the oncological safety of autologous fat ...

Preliminary data on the oncological safety of autologous fat transfer (AFT) for total breast reconstruction from the BREAST trial. J Plast ...

9.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-022-09485-5

The oncological safety of autologous fat grafting - BMC Cancer

According to the current evidence, AFG is a safe technique of breast reconstruction for patients that have undergone BC surgery and did not affect OS, DFS, or ...