Trials / Completed
CompletedNCT04783818
Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
Multicenter Retrospective Evaluation Study of the Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,200 (actual)
- Sponsor
- Humanitas Clinical and Research Center · Academic / Other
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Adjuvant Radiotherapy | PMRT |
Timeline
- Start date
- 2020-06-06
- Primary completion
- 2020-11-23
- Completion
- 2021-01-25
- First posted
- 2021-03-05
- Last updated
- 2021-03-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04783818. Inclusion in this directory is not an endorsement.