Clinical trial NCT04783818: Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
Official title: Multicenter Retrospective Evaluation Study of the Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mammaplasty
Radiotherapy; Complications
Breast Implant; Complications
Transplant Failure
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
Collaborators: name: Marco Klinger
name: Marta Scorsetti
name: Davide Franceschini
name: Emanuela Morenghi
First posted: 2021-03-05
Enrollment: 3200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of some Breast Units in Italy

Brief summary: For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life.

There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.

Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes.

Despite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction.

However, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction.

In particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting.

The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.


Eligibility criteria: Inclusion Criteria:

* Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)

Exclusion Criteria:

* Delayed prosthetic reconstruction

Primary outcomes:
measure: Reconstruction failure
timeFrame: 2 years
Secondary outcomes:
measure: Reconstruction Complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: Humanitas Hospital, Italy
name: Marco Klinger
role: STUDY_DIRECTOR
affiliation: Humanitas Hospital, Italy
name: Davide Franceschini
role: STUDY_CHAIR
References:
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citation: Caviggioli F, Maione L, Klinger F, Lisa A, Klinger M. Autologous Fat Grafting Reduces Pain in Irradiated Breast: A Review of Our Experience. Stem Cells Int. 2016;2016:2527349. doi: 10.1155/2016/2527349. Epub 2015 Dec 29.