Breast Cancer Clinical Trial
Official title:
A Pilot Study Treating Radiation Injury With Autologous Fat Transfer
Verified date | May 2023 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Summer E Hanson | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
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 |
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