Clinical trial NCT05890196: Autologous Fat Grafting in Radiated Soft Tissue Reconstruction
Official title: A Pilot Study Treating Radiation Injury With Autologous Fat Transfer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer
Radiation Fibrosis
Fat Grafting
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll participants from the University of Chicago who are undergoing autologous fat grafting as part of their reconstruction for breast cancer.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Skin Fibrometry before and after fat transfer in reconstruction.
timeFrame: 12 months
Secondary outcomes:
measure: Change in Radiation Injury before and after fat transfer.
timeFrame: 12 months
measure: Change in patient reported satisfaction of the breast measure before and after fat transfer.
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Summer E Hanson
state: Illinois
Study officials:
References:
citation: Pattani N, Sanghera J, Langridge BJ, Frommer ML, Abu-Hanna J, Butler P. Exploring the mechanisms behind autologous lipotransfer for radiation-induced fibrosis: A systematic review. PLoS One. 2024 Jan 25;19(1):e0292013. doi: 10.1371/journal.pone.0292013. eCollection 2024.
citation: Zheng M, Liu Z, He Y. Radiation-induced fibrosis: Mechanisms and therapeutic strategies from an immune microenvironment perspective. Immunology. 2024 Aug;172(4):533-546. doi: 10.1111/imm.13788. Epub 2024 Apr 1.