Autologous Fat Grafting in Radiated Soft Tissue Reconstruction

Breast Cancer Clinical Trial

Official title:

A Pilot Study Treating Radiation Injury With Autologous Fat Transfer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05890196
• Other study ID #: IRB21-1183
• Status: Enrolling by invitation
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to observe the effect of autologous fat grafting on soft tissue reconstruction of the breast following radiation treatment. Moving fat from one part of the body to another has been used for reconstruction for hundreds of years. However, it is not fully understood how well this works in reconstruction after radiation is used for cancer treatment.

Description:

This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing AFT for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. As this is a pilot study, the study team plans to enroll ten (10) patients to demonstrate the feasibility of the protocol and pathway as well as establish preliminary data for extramural funding. The research will include capturing 2-dimensional (2-D) and 3-dimensional (3-D) photographs as well as ultrasound (US) soft tissue assessments to determine volume retention and changes in the reconstructed area. Participants will undergo this imaging of their breast and chest wall and complete two questionnaires to evaluate patient satisfaction, quality of life, and late effects of radiation following fat grafting over a 12-month period, all standard of care. The 3D photographs and US are routinely used in practice but will be performed for research purposes in this study.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to give consent

• Undergoing elective autologous fat grafting

• Previously treated for breast cancer

• Previous treatment included radiation therapy to the breast/chest wall.

Exclusion Criteria:

• Unable to give consent

• No history of radiation to the breast or chest wall

• No prior treatment for breast cancer

• No indication for autologous fat grafting

• Currently pregnant or breastfeeding

• Currently consuming nicotine products (smoking, vaping, patches, gum)

• Under the age of 18

Related Conditions & MeSH terms

• Breast Cancer
• Fat Grafting
• Radiation Fibrosis

Locations

Country	Name	City	State
United States	Summer E Hanson	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Skin Fibrometry before and after fat transfer in reconstruction.	Soft tissue assessment is made using a non-invasive device SkinFibrometer (Delfin Kuopio, Finland) that measures tissue edema and skin elasticity. Measurements will be taken in all four quadrants of the affected (radiated) breast or reconstructed breast before and after the grafting procedure.	12 months
Secondary	Change in Radiation Injury before and after fat transfer.	Radiation injury assessment is made using the validated tool Late Effects Normal Tissue Task Force - Subjective Objective Management and Analytic (LENT-SOMA) score. Assessment will be made before and after the fat transfer procedure. Overall, scores are based on 12 categories, scored 0-4 with a higher score indicating more significant radiation injury.	12 months
Secondary	Change in patient reported satisfaction of the breast measure before and after fat transfer.	The BREAST Q validated patient survey measures several realms related to breast reconstruction and allows an assessment of satisfaction and physical well-being before and after reconstruction. The survery responses are tallied and converted to a score of 100 with a higher score being more satisfied or better outcome. In addition, a change in score of 8 or more points is a clinically meaningful difference according to normative studies.	12 months