Clinical trial NCT04261829: AFT: Introduction of a Full Breast Reconstructive Method
Official title: Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Reconstructive Surgery
Breast Reconstruction
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2020-02-10
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients or women who, due to a gene mutation have a significantly high risk of developing breast cancer, decide to undergo profylactic mastectomy.

Brief summary: A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.


Eligibility criteria: Inclusion Criteria:

* Female gender
* Age of 18 years and older
* History or in candidate for a mastectomy procedure in the near future
* Patients undergoing preventive mastectomy
* Patients' choice to undergo a breast reconstruction
* Wanting to participate in this study
* Patient is able to wear the external expansion device

Exclusion Criteria:

* Active smoker or a history of smoking 4 weeks prior to surgery
* Current substance abuse
* History of lidocaine allergy
* History of silicone allergy
* 4 weeks or less after chemotherapy
* History of radiation therapy in the breast region
* Oncological treatment includes radiotherapy after mastectomy
* Kidney disease
* Steroid dependent asthma (daily or weekly) or other diseases
* Immune-suppressed or compromised disease
* Uncontrolled diabetes
* BMI\>30
* Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C
* Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction
* The treating plastic surgeon has strong doubts on the patient's treatment compliance

Primary outcomes:
measure: Breast-related Quality of life
timeFrame: 2 years
Secondary outcomes:
measure: Aesthetic result
timeFrame: 2 years
measure: Complications
timeFrame: 2 years
measure: Oncological safety
timeFrame: 5 years
measure: Cost-effectiveness
timeFrame: 2 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
state: Limburg
city: Venlo
country: Netherlands
facility: Viecuri Venlo
state: Limburg
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center (VUMC)
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Bilthoven
country: Netherlands
facility: Alexander Monro, Bilthoven
city: Breda
country: Netherlands
facility: Amphia
city: Hengelo
country: Netherlands
facility: Ziekenhuis groep Twente (ZGT)
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
Study officials:
affiliation: Maastricht University Medical Center
name: Andrzej Piatkowski de Grzymala, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: