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

Radiotherapy; Complications Clinical Trial

Official title:

Multicenter Retrospective Evaluation Study of the Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783818
• Other study ID #: 49/20
• Status: Completed
• Start date: June 6, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: March 2021
• Source: Humanitas Clinical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3200
• Est. completion date: January 25, 2021
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Implant; Complications
• Mammaplasty
• Radiotherapy; Complications
• Transplant Failure

Intervention

Radiation:
• Adjuvant Radiotherapy
PMRT

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (5)

Lead Sponsor	Collaborator
Humanitas Clinical and Research Center	Davide Franceschini, Emanuela Morenghi, Marco Klinger, Marta Scorsetti

Country where clinical trial is conducted

Italy, 

References & Publications (10)

Al-Ghazal SK, Fallowfield L, Blamey RW. Comparison of psychological aspects and patient satisfaction following breast conserving surgery, simple mastectomy and breast reconstruction. Eur J Cancer. 2000 Oct;36(15):1938-43. — View Citation

Ascherman JA, Hanasono MM, Newman MI, Hughes DB. Implant reconstruction in breast cancer patients treated with radiation therapy. Plast Reconstr Surg. 2006 Feb;117(2):359-65. — View Citation

Berry T, Brooks S, Sydow N, Djohan R, Nutter B, Lyons J, Dietz J. Complication rates of radiation on tissue expander and autologous tissue breast reconstruction. Ann Surg Oncol. 2010 Oct;17 Suppl 3:202-10. doi: 10.1245/s10434-010-1261-3. Epub 2010 Sep 19. — View 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. — View Citation

Chang DW, Barnea Y, Robb GL. Effects of an autologous flap combined with an implant for breast reconstruction: an evaluation of 1000 consecutive reconstructions of previously irradiated breasts. Plast Reconstr Surg. 2008 Aug;122(2):356-362. doi: 10.1097/PRS.0b013e31817d6303. — View Citation

Christante D, Pommier SJ, Diggs BS, Samuelson BT, Truong A, Marquez C, Hansen J, Naik AM, Vetto JT, Pommier RF. Using complications associated with postmastectomy radiation and immediate breast reconstruction to improve surgical decision making. Arch Surg. 2010 Sep;145(9):873-8. doi: 10.1001/archsurg.2010.170. — View Citation

Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008 Oct 9;359(15):1590-601. doi: 10.1056/NEJMct0802899. Review. — View Citation

Nahabedian MY, Tsangaris T, Momen B, Manson PN. Infectious complications following breast reconstruction with expanders and implants. Plast Reconstr Surg. 2003 Aug;112(2):467-76. — View Citation

Recht A, Comen EA, Fine RE, Fleming GF, Hardenbergh PH, Ho AY, Hudis CA, Hwang ES, Kirshner JJ, Morrow M, Salerno KE, Sledge GW Jr, Solin LJ, Spears PA, Whelan TJ, Somerfield MR, Edge SB. Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update. Pract Radiat Oncol. 2016 Nov - Dec;6(6):e219-e234. doi: 10.1016/j.prro.2016.08.009. Epub 2016 Sep 19. Review. — View Citation

Yanko-Arzi R, Cohen MJ, Braunstein R, Kaliner E, Neuman R, Brezis M. Breast reconstruction: complication rate and tissue expander type. Aesthetic Plast Surg. 2009 Jul;33(4):489-96. doi: 10.1007/s00266-008-9192-0. Epub 2008 Jun 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reconstruction failure	Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)	2 years
Secondary	Reconstruction Complications	Rate of capsular contracture and rate of need for reintervention	2 years