Clinical trial NCT03737500: Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer
Official title: Standard Silicone-based Breast Implant vs. B-Lite® Light Weight Breast Implant for Reconstructive Surgery After Total Mastectomy and Post-Mastectomy Radiotherapy for Breast Cancer: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Implant; Complications
Breast Implant Protrusion
Breast Cancer
Radiotherapy Side Effect
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such complications are promoted by elastic properties of tissues and their response to gravity forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic outcome may result up to breast implant exposure, and its removal may become necessary, thus compromising the quality of breast reconstruction. These complications are further favoured by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and thinning. Since PMRT has been associated to improved loco-regional control in node-positive breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved loco-regional control but, on the other hand, it has increased the failure rate of breast reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate vs. two-staged by use of tissue expander) has not decreased the complications rate after PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT ranges from 0% to 40%. The present study will recruit 80 participants affected by breast cancer candidated to total mastectomy with immediate breast reconstruction and subsequent PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then definitive reconstruction with breast implant. Participants will be randomized in two experimental arms: 40 patients will receive final reconstruction by the use of standard silicone-based breast implant and the other 40 patients will receive B-Lite® light weight breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant removal). Secondary end-points include the overall complications rate, MRI evaluation of breast implant and surrounding tissues, cosmetic outcomes and quality of life including participants' satisfaction with breast reconstruction.


Eligibility criteria: Inclusion Criteria:

* Breast cancer diagnosis with indication of total mastectomy and breast reconstruction
* Indication of post-mastectomy radiation therapy
* Availability to be followed up for 24 months
* Signature of informed consent

Exclusion Criteria:

* Patients candidated to breast-conserving surgery
* Contraindicated breast reconstruction (severe comorbidities, unfavourable survival outcome expected, distant metastases)
* Patients affected by other solid malignancies
* Pregnancy
* Participation to other clinical studies in the last three months

Primary outcomes:
measure: Failure rate of breast reconstruction
timeFrame: 24 months
Secondary outcomes:
measure: Overall complications rate
timeFrame: 24 months
measure: Magnetic resonance imaging (MRI) of breast implant and surrounding tissues
timeFrame: 6 months
measure: Change in cosmetic outcome
timeFrame: 1, 6, 12, 24 months
measure: Change in Quality of life (QoL) measured with BIBCQ
timeFrame: 6, 12, 24 months
measure: Change in Quality of life (QoL) measured with BREAST-Q
timeFrame: 6, 12, 24 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Breast Unit - Istituti Clinici Scientifici Maugeri Spa SB
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri Spa SB
name: Fabio Corsi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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