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

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ClinicalTrials.gov Identifier: NCT03981718
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio J. Forte, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Fat grafting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipose-Induced Regeneration of Breast Skin (AIR Breast) to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients: A Randomized, Prospective Pilot Study
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
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 2
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




Primary Outcome Measures :
  1. Increase in skin quality [ Time Frame: 18 months ]
    Number of subjects to show reverse radiation-induced skin injury

  2. Physical Well-Being Using the BREAST-Q Reconstruction Module [ Time Frame: 12 months, 18 months ]
    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.

  3. Effects of skin disease on quality of life [ Time Frame: 12 months, 18 months ]
    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.

  4. Skin Toxicity Costs [ Time Frame: 12 months, 18 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03981718


Contacts
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Contact: Mauricia A Buchanan, RN 904-953-2077 buchanan.mauricia@mayo.edu
Contact: Carolyn Lindeman, RN 904-953-2077 lindeman.carolyn@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Antonio Forte, MD, PhD Mayo Clinic

Additional Information:
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Responsible Party: Antonio J. Forte, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03981718     History of Changes
Other Study ID Numbers: 19-002792
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Breast Neoplasms
Radiation Injuries
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Wounds and Injuries