Breast Reconstruction Following Breast Cancer in Very High Risk Patients

NCT03261323 | Withdrawn DMC

• 1 other identifier: CASE10116
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 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. 2.Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications

Conditions

Breast Cancer; Malignant Neoplasm of Breast

Keywords

Breast Reconstruction; Mastectomy

Outcome Measures

Primary Outcomes (1)

• optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications

  Proportion of patients preferring delayed reconstruction.

  Until 1 year post breast reconstruction

Secondary Outcomes (5)

• Major complications

  Until 1 year post breast reconstruction

• Minor complications

  Until 1 year post breast reconstruction

• Number of revision surgeries

  Until 1 year post breast reconstruction

• Hospital cost of the complete reconstruction treatment

  Until 1 year post breast reconstruction

• Change in patient satisfaction

  Until 1 year post breast reconstruction

Other Outcomes (1)

• Aesthetic evaluation

  Until 1 year post breast reconstruction

Study Arms (2)

Immediate breast reconstruction

ACTIVE COMPARATOR

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.

Procedure: Immediate Breast Reconstruction; Other: Breast-Q questionnaire

Delayed breast reconstruction

EXPERIMENTAL

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.

Procedure: Delayed Breast Reconstruction; Other: Breast-Q questionnaire

Interventions

Immediate Breast Reconstruction PROCEDURE

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

Delayed Breast Reconstruction PROCEDURE

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

Breast-Q questionnaire OTHER

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

Delayed breast reconstruction; Immediate breast reconstruction

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
• Subjects must be breast reconstruction candidates using implant based breast reconstruction.
• Subjects must have a pre-operative risk \>20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Prior breast cancer surgical treatment
• Prior breast reconstruction
• Inability to provide written consent

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Risal Djohan, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: August 25, 2017
• Study Start: May 31, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

US (1)