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

NCT03981718 | Withdrawn

• 2 other identifiers: 19-002792NCI-2022-11026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group: Standard

ACTIVE COMPARATOR

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

Group: Experimental

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

Interventions

Fat grafting PROCEDURE

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

Group: Experimental; Group: Standard

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonio Forte, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: May 17, 2019
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)