Adipose-Induced Regeneration of Breast Skin to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients

Adipose-Induced Regeneration of Breast Skin (AIR Breast) to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients: A Randomized, Prospective Pilot Study

Researchers are trying to identify the therapeutic effect of injection into the subcutaneous tissue to treat radiation-induced skin injury of post mastectomy in patients with breast cancer.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Fat grafting

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Females above 18 years old
• Diagnosis with breast cancer, who will be treated by mastectomy and undergo radiotherapy, and will receive breast reconstruction
• Able and willing to sign consent to participate

Exclusion Criteria:

• Breast cancer patients that do not accept to participate
• Patients with previous breast reconstruction surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group: Standard; Breast cancer subjects with current injury to irradiated skin at the post-mastectomy site will receive fat grafting procedure per standard of care during their 2nd stage breast reconstruction.	Procedure: Fat grafting; Lipoaspirates will be collected from the own subjects abdominal fat tissue, during the 2nd stage breast reconstruction and will be injected on each affected breast during the insertion of the permanent breast implant in the 2nd stage of breast reconstruction
Experimental: Group: Experimental; Breast cancer subjects with current injury to irradiated skin at the post-mastectomy site will receive their fat grafting procedure until 6 months after their 2nd stage breast reconstruction.	Procedure: Fat grafting; Lipoaspirates will be collected from the own subjects abdominal fat tissue, during the 2nd stage breast reconstruction and will be injected on each affected breast during the insertion of the permanent breast implant in the 2nd stage of breast reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in skin quality	Number of subjects to show reverse radiation-induced skin injury	18 months
Physical Well-Being Using the BREAST-Q Reconstruction Module	Change in BREAST-Q patient-reported questionnaire to assess quality of life and patient satisfaction by using questions pertaining to the function and participation in activities after fat grafting. Subjects are asked to answer 16 questions on how often they experienced each symptom, using a score of 1 to 5, where 1 was none of the time and 5 was very often. Answers from these questions were combined to provide a total physical well-being score (for a total possible range of 16-80). Lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.	12 months, 18 months
Effects of skin disease on quality of life	Change in patient-reported Skin-16 questionnaire used to assess skin condition after fat grafting by using 16 questions on how often subjects skin condition has bothered them during the past week, using a score of 0 to 6, where 0 is never bothered and 10 is always bothered.	12 months, 18 months
Skin Toxicity Costs	Change in patient-reported skin toxicity costs questionnaire used to assess the economic impact of skin changes due to radiation after fat grafting by using 7 questions asking subjects to report total costs and itemized spending on specific items related to post procedure care.	12 months, 18 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Antonio Forte, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2019
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Breast Neoplasms; Radiation Injuries
• Other Study ID Numbers: 19-002792; NCI-2022-11026 (Registry Identifier: NCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No