Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.

Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.

Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy.

Immediate Breast Reconstruction

Risk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery.

Delayed Breast Reconstruction

Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment

Breast-Q questionnaire

Risal Djohan, MD

The purpose of this study is to:

1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs
2. Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications

Primary Endpoint(s)

1. Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort
2. Compare immediate and delayed reconstruction outcome metrics through retrospective review

Secondary Endpoint(s)

1. Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction.
2. Compare complications and reoperations between immediate versus delayed reconstruction.
3. Compare the hospital costs between immediate versus delayed reconstruction
4. Evaluate the effectiveness of risk reduction strategies

Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study

Aesthetic evaluation using postoperative photos one year after the first surgery, and after the final reconstruction surgery

Proportion of patients preferring delayed reconstruction.

defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc).

defined as the ones that were office treated, not requiring a reoperation

defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal

Cost of reconstruction including the cost of complications

Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up

Case Comprehensive Cancer Center

Carcinoma

Approximately 3 months after postmastectomy radiation therapy, the preserved, irradiated, and re-inflated breast skin will be used to perform the delayed breast reconstruction. During the stage 2 reconstruction, the implant or expander will be removed and the definitive reconstruction will be performed with the preserved breast skin utilizing a preference for autologous tissue or autologous tissue with an implant due to the potential for complications with implant-based reconstructions after radiation therapy (XRT).

Steven J. Kronowitz, MD

The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the standard approach (reconstruction that is not started until radiation treatment is completed).

Study Visits and Surgeries:

You will be hospitalized 2-4 times for 1-5 days depending on your condition. If you agree to take part in this study, you will be scheduled for a skin-sparing mastectomy. The following tests and procedures will be performed:

Pre-Operative Visit:

* Your complete medical history will be updated.
* The doctor will determine what type of reconstructive surgery can be done.
* You will have photos taken of your breasts. Your face, hair, or jewelry will not be photographed. These photos will be kept in a password-protected computer accessible only by the principle investigator and people directly involved in this study.
* You will complete a quality of life questionnaire. The questionnaire asks about how satisfied you are with your appearance. The questionnaire will be sent by email, US postal service mail, or in person when you come for your follow up visits. The questionnaire should take about 20 minutes to complete. If sent by US postal service, you will be given a postage-paid envelope to return the questionnaire.

At your Mastectomy Surgery:

* Your complete medical history will be updated.
* You will have photos taken of your breasts.
* During the surgery, a tissue expander will be placed in your breast. Sterile salt water will be added to inflate the expander and a small skin sample (about the size of a pencil eraser) from the breast will be taken to study stretching and scarring of the skin. The tissue will be securely maintained at MD Anderson.
* You will be monitored for any problems.

Post-Operative Visit - 7 to 10 Days after Mastectomy Surgery:

* The study staff will look at the results of your surgery.
* Your complete medical history will be updated.
* You will complete the quality of life questionnaire.
* You will be asked about any problems you may be having.

Deflation Visit - Week 5:

* Your complete medical history will be updated.
* You will have photos taken of your breasts.
* The sterile salt water in the expander will be let out, causing the breast to go flat. This is done by inserting a needle into a special port and withdrawing the fluid with a syringe.

Radiation Visit - Week 8:

* You must have radiation either at M. D. Anderson or an M. D. Anderson-affiliated site.
* Extra fluid may be added to the tissue expander before radiation.
* The study staff will look at the results of your surgery.
* You will be asked about any problems you may be having.
* You will receive radiation, typically 5 days a week for 6 weeks.

Post-Radiation Visits - About Week 13 and every 2 to 4 Weeks after:

* Your complete medical history will be updated.
* The study staff will look at the results of your surgery.
* You will be asked about any problems you may be having.
* You will complete the quality of life questionnaire.
* Your expander will be re-inflated.

Delayed-delayed Reconstruction Surgery - At about Week 23:

* Your complete medical history will be updated.
* You will have photos taken of your breasts.
* During surgery, you will be monitored for any problems. A tissue sample will be collected to study stretching and scarring of the skin from the mastectomy incision and the tissue that is used to form the new breast. The tissue will be securely maintained at MD Anderson.
* During surgery, you will have tissue moved from your lower abdomen, back, or buttock to be used for reconstruction. A silicone or saline breast implant may or may not be used to help construct the breast. The amount of tissue used for building the breast will depend on your body size and donation site. Your reconstructive surgeon will discuss this with you before surgery.
* During surgery, the expander will be removed and reconstruction of your breast will occur.

Follow-Up Surgery - At about Week 47:

* Your complete medical history will be updated.
* You will have photos taken of your breasts.
* You will complete the quality of life questionnaire.
* During surgery, you will be monitored for any problems and a tissue sample will be collected.
* During this surgery, procedures will be done to improve the appearance of the breast.

Long-Term Follow-Up Visits - At 6, 12, 24, and 36 Months:

* Your complete medical history will be updated.
* You will have photos taken of your breasts.
* You will be asked about any problems you may be having.
* At Months 12 and 24, you will complete the quality of life questionnaire.

This is an investigational study. The implants in this study have been FDA approved for skin expansion as a method of breast reconstruction. The use of the implants is investigational in this study.

Up to 200 women will take part in this study. All will be enrolled at M. D. Anderson.

Delayed-Delayed Breast Reconstruction

A Multidisciplinary Protocol for Planned Skin-Preserving Delayed Breast Reconstruction for Patients With Locally Advanced Breast Cancer Requiring Postmastectomy Radiation Therapy

Overall complication defined as any of the following complications post breast reconstruction surgery: seroma, hematoma, wound dehiscence, partial flap loss, total flap loss, infection, flap microvascular thrombosis (arterial or venous), venous congestion of flap, flap fat necrosis, mastectomy skin flap necrosis, exposure breast implant, capsular contracture, and delayed wound healing.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breast Reconstruction Following Breast Cancer in Very High Risk Patients	NCT03261323	Breast Cancer Malignant Neopl...	Immediate Breas... Delayed Breast ... Breast-Q questi...	19 Years -	Case Comprehensive Cancer Center
Breast Reconstruction Following Breast Cancer in Very High Risk Patients	NCT03261323	Breast Cancer Malignant Neopl...	Immediate Breas... Delayed Breast ... Breast-Q questi...	19 Years -	Case Comprehensive Cancer Center
Breast Reconstruction Following Breast Cancer in Very High Risk Patients	NCT03261323	Breast Cancer Malignant Neopl...	Immediate Breas... Delayed Breast ... Breast-Q questi...	19 Years -	Case Comprehensive Cancer Center
Delayed-Delayed Breast Reconstruction	NCT01256528	Breast Cancer	Delayed Breast ...	18 Years -	M.D. Anderson Cancer Center
Delayed-Delayed Breast Reconstruction	NCT01256528	Breast Cancer	Delayed Breast ...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for delayed breast reconstruction