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Breast Reconstruction Following Breast Cancer in Very High Risk Patients

NCT03261323 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-05-20

No results posted yet for this study

Summary

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

Conditions

Interventions

PROCEDURE

Immediate Breast Reconstruction

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.

PROCEDURE

Delayed 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.

OTHER

Breast-Q questionnaire

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

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Risal Djohan, MD · Cleveland Clinic, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03261323 on ClinicalTrials.gov