Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients

N/ANot Yet RecruitingNCT07641985

Maastricht University Medical Center280 enrolled

Overview

The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following mastectomy. It will also evaluate patient satisfaction, quality of life, complication rates, and cost-effectiveness of both reconstruction techniques. The main questions it aims to answer are: Does AFT result in non-inferior patient satisfaction with the reconstructed breast compared to DIEP flap reconstruction 12 months after the final operation? Does AFT result in fewer major complications and improved cost-effectiveness compared to DIEP flap reconstruction? Are quality of life outcomes and oncologic safety comparable between AFT and DIEP flap reconstruction in irradiated patients? Researchers will compare AFT to DIEP flap reconstruction to see if AFT can provide similar reconstructive outcomes with lower morbidity and fewer complications in irradiated breast cancer patients. Participants will: Undergo breast reconstruction using either AFT or DIEP flap reconstruction Attend follow-up visits for clinical examinations, imaging, and assessment of complications Complete questionnaires about breast satisfaction, quality of life, and recovery during follow-up Be monitored for oncologic safety and reconstructive outcomes for 12 months after the final operation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

280

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female, aged \>18 years. * BMI between \> 22 and \<35 kg/m2 * History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment). * May include contralateral/bilateral prophylactic mastectomy if at least one side had cancer and radiation. * Desires autologous breast reconstruction and accepts randomization between AFT and DIEP. * Medically fit for surgery (ASA I-III). * Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature). * No evidence of active cancer at enrollment; remission confirmed. * Able to wear the EVE device (if randomized in AFT). * Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up. Exclusion Criteria: * Prior autologous breast reconstruction on the intended side. BMI \<22 or \>35 kg/m2 * Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators). * Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability). * Current chemotherapy or completed less than 4 weeks prior to enrollment. * Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure). * Active smoker or not abstinent for at least 6 weeks pre-operatively. * Pregnant at time of enrollment. * In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans). * Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction). * Allergy to lidocaine or silicone

Outcomes

Primary Outcomes

to determine whether autologous fat transfer (AFT) is non-inferior to DIEP flap breast re-construction regarding breast satisfaction, as measured by the BREAST-Q, 12 months after the final reconstructive procedure in irradiated breast cancer patients;

One of the primary outcomes is the BREAST-Q "Satisfaction with Breasts" score at 12 months post-reconstruction. This validated, patient-reported measure (0-100 scale) as-sesses satisfaction with breast appearance and feel.

Time frame: 12 months

to assess whether AFT is superior to DIEP flap reconstruction in terms of the incidence of major complications requiring reoperation or hospital readmission.

The second primary outcome measure is the incidence of major complications (i.e. complications requiring reoperation or hospital readmission such as hematoma, venous/arterial insufficiency, partial/total flap loss, and infection/abscess).

Time frame: 12 months

cost-effectiveness of AFT compared with DIEP flap reconstruction will be evaluated.

The third primary outcome is cost-effective-ness. We will collect detailed healthcare and societal costs per patient using hospital records, CRFs, and a study-adapted patient-reported iMCQ and iPCQ (for health care resource use and productivity loss). QALYs will be calculated from EQ-5D-5L data at multiple timepoints. We will compare cost per QALY (ICER) between AFT and DIEP, and conduct a budget impact analysis.

Time frame: 12 months

Secondary Outcomes

Physical Well-being: Abdomen (BREAST-Q)

Physical Well-being: Abdomen (donor site), assessed using the BREAST-Q Reconstruction Module. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better physical well-being of the abdominal donor site.

Time frame: 12 months

Complications (Minor & General)

Incidence of minor recipient-site and donor-site com-plications (i.e. complications taking care of at the outpatient clinic) managed conserva-tively (e.g. wound problems/dehiscence, infection, seroma, hematoma, and abdominal bulging), and any general (systemic) complications related to surgery or hospitalization (e.g. pulmonary embolism, pneumonia).

Time frame: 12 months

Oncologic Safety

Monitor and compare breast cancer recurrence rates using routine follow-up and PALGA registry to confirm AFT's oncologic safety.

Time frame: 12 months

Sensory Recovery

Evaluate return of breast skin sensation at 12 months with mono-filament testing to compare sensory outcomes between techniques \[in MUMC+ only\].

Time frame: 12 months

Physical Function and Pain

We will assess post-mastectomy pain and phantom sensations using relevant BREAST-Q items or a brief questionnaire. For donor site function, DIEP patients may be asked about core strength (e.g. sit-ups), while AFT patients will be monitored for minor issues like contour irreg-ularities. Assessments will be based on patient reports and clinical exam.

Time frame: 12 months

Breast Aesthetics & Volume

Breast volume and shape assessed 12 months after reconstruction using 3D Vectra photography and the BREAST-V volume calculator (https://braflap.com/breast-v/, Sternal Notch - Nipple distance \[cm\], Fold Projection - Inframammary Fold distance \[cm\], and Nipple - Inframammary Fold distance \[cm\]) . Fat graft retention in the AFT group will be estimated by total grafted volume versus final breast volume. Standardized photographs (2D and 3D) will document cosmetic out-comes which can be assessed by a an expert panel.

Time frame: 12 months

Radiation-Associated Changes

We will grade radiation fibrosis/telangiectasia in the chest skin at baseline (just before recon) and at 12 months, using the Common Terminology Criteria for Adverse Events (CTCAE) score (for radiation dermatitis/fibrosis). If AFT improves the pliability or vascularity of skin, we might see an improvement in grade (e.g. from CTCAE 2 to 1). If DIEP flap breast reconstruction brings fresh skin, the radiated skin might be partially replaced or supplemented. This is some-what subjective, but we will attempt consistent grading. Also, if any ulcers or non-healing radi-ation damage was present, we will see if healed after reconstruction

Time frame: 12 months

Physical Well-being: Chest (BREAST-Q)

Physical Well-being: Chest, assessed using the BREAST-Q Reconstruction Module. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better physical well-being of the chest.

Time frame: 12 months

Sexual Well-being (BREAST-Q)

Sexual Well-being, assessed using the BREAST-Q Reconstruction Module. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better sexual well-being.

Time frame: 12 months

Breast Sensation (BREAST-Q)

Breast Sensation, assessed using the BREAST-Q Sensation Module. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better breast sensation.

Time frame: 12 months

Donor Site Satisfaction (BODY-Q)

Satisfaction with donor site appearance, assessed using the BODY-Q. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating greater satisfaction with the donor site.

Time frame: 12 months

Adverse Effects of Radiation (BREAST-Q)

Adverse Effects of Radiation, assessed using the BREAST-Q Reconstruction Module. Scores are transformed to a scale ranging from 0 to 100. Specify according to the scoring manual whether higher scores indicate fewer or more adverse effects of radiation.

Time frame: 12 months

Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes