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Breast Reconstruction Following Breast Cancer in Very High Risk Patients

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ClinicalTrials.gov Identifier: NCT03261323
Recruitment Status : Not yet recruiting
First Posted : August 25, 2017
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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

Condition or disease Intervention/treatment Phase
Breast Cancer Malignant Neoplasm of Breast Procedure: Immediate Breast Reconstruction Procedure: Delayed Breast Reconstruction Other: Breast-Q questionnaire Not Applicable

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Immediate breast reconstruction
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
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.

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

Experimental: Delayed breast reconstruction
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
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




Primary Outcome Measures :
  1. optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications [ Time Frame: Until 1 year post breast reconstruction ]
    Proportion of patients preferring delayed reconstruction.


Secondary Outcome Measures :
  1. Major complications [ Time Frame: Until 1 year post breast reconstruction ]
    defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc).

  2. Minor complications [ Time Frame: Until 1 year post breast reconstruction ]
    defined as the ones that were office treated, not requiring a reoperation

  3. Number of revision surgeries [ Time Frame: Until 1 year post breast reconstruction ]
    defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal

  4. Hospital cost of the complete reconstruction treatment [ Time Frame: Until 1 year post breast reconstruction ]
    Cost of reconstruction including the cost of complications

  5. Change in patient satisfaction [ Time Frame: Until 1 year post breast reconstruction ]
    Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up


Other Outcome Measures:
  1. Aesthetic evaluation [ Time Frame: Until 1 year post breast reconstruction ]
    Aesthetic evaluation using postoperative photos one year after the first surgery, and after the final reconstruction surgery



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261323


Contacts
Contact: Risal Djohan, MD 440-878-2500 djohanr@ccf.org
Contact: Stephen Grobmyer, MD 216-636-2843 grobmys@ccf.org

Locations
United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Risal Djohan, MD    440-878-2500    djohanr@ccf.org   
Principal Investigator: Risal Djohan, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Risal Djohan, MD Cleveland Clinic, Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03261323     History of Changes
Other Study ID Numbers: CASE10116
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Case Comprehensive Cancer Center:
Breast Reconstruction
Mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases