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Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

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ClinicalTrials.gov Identifier: NCT04783818
Recruitment Status : Completed
First Posted : March 5, 2021
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
Marco Klinger
Marta Scorsetti
Davide Franceschini
Emanuela Morenghi
Information provided by (Responsible Party):
Andrea Lisa, Humanitas Clinical and Research Center

Study Description
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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.


Condition or disease Intervention/treatment
Mammaplasty Radiotherapy; Complications Breast Implant; Complications Transplant Failure Radiation: Adjuvant Radiotherapy

Study Design
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Study Type : Observational
Actual Enrollment : 3200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Multicenter Retrospective Evaluation Study of the Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
Actual Study Start Date : June 6, 2020
Actual Primary Completion Date : November 23, 2020
Actual Study Completion Date : January 25, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
One Stage Reconstruction With Adjuvant Radiotherapy Radiation: Adjuvant Radiotherapy
PMRT
Two Stage Reconstruction With Adjuvant Radiotherapy Radiation: Adjuvant Radiotherapy
PMRT
Autologous Reconstruction With Adjuvant Radiotherapy Radiation: Adjuvant Radiotherapy
PMRT
One Stage Reconstruction Without Adjuvant Radiotherapy
Two Stage Reconstruction Without Adjuvant Radiotherapy
Autologous Reconstruction Without Adjuvant Radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Reconstruction failure [ Time Frame: 2 years ]
    Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)


Secondary Outcome Measures :
  1. Reconstruction Complications [ Time Frame: 2 years ]
    Rate of capsular contracture and rate of need for reintervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients of some Breast Units in Italy
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783818


Locations
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Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Humanitas Clinical and Research Center
Marco Klinger
Marta Scorsetti
Davide Franceschini
Emanuela Morenghi
Investigators
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Study Director: Marco Klinger Humanitas Hospital, Italy
Study Chair: Davide Franceschini Humanitas Hospital, Italy
More Information
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Publications:

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Responsible Party: Andrea Lisa, Principal Investigator, Humanitas Clinical and Research Center
ClinicalTrials.gov Identifier: NCT04783818    
Other Study ID Numbers: 49/20
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No