Clinical trial NCT02339779: Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy
Official title: the Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: fat grafting
fat injection
lipoaspirate
fat transfer
lipofilling
liposculpturing
lipoinjection
lipotransfer
breast reconstruction
external pre-expansion
BRAVA
EVE
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2015-01-15
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT (intervention group) or reconstruction with implants (control group). AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness.


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' choice to undergo a breast reconstruction
* Wanting to participate in this study
* Patient is able to wear the BRAVA 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
* Claustrophobia for an MRI-scan

Primary outcomes:
measure: Breast-related Quality of life (BREAST_Q)
timeFrame: 1 year
Secondary outcomes:
measure: Aesthetic result
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
measure: Oncological safety
timeFrame: 5 years
measure: Cost-effectiveness
timeFrame: 1 year
measure: Sensibility
timeFrame: 1 year
measure: Donor site satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Amstelveen
country: Netherlands
facility: Amstelland Hospital
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Bilthoven
country: Netherlands
facility: Alexander Monro Breast cancer hospital
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Hague
country: Netherlands
facility: Bronovo-MCH Hospital
city: Hengelo
country: Netherlands
facility: Ziekenhuis Groep Twente Hospital
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre (MUMC+)
Study officials:
affiliation: Maastricht University Medical Center
name: Andrzej Piatkowski de Grzymala, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schop SSJ, Hommes JE, Krastev TK, Derks D, Larsen M, Rakhorst H, Schmidbauer U, Smit JM, Tan T, Wehrens K, de Wit T, van der Hulst RRWJ, Piatkowski de Grzymala AA. BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial. BMJ Open. 2021 Sep 16;11(9):e051413. doi: 10.1136/bmjopen-2021-051413.