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

Mayo Clinic

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Procedure: Fat grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT03981718

19-002792

NCI-2022-11026 (Registry Identifier)

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group: Standard

Active Comparator group

Description:

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.

Treatment:

Procedure: Fat grafting

Group: Experimental

Experimental group

Description:

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.

Treatment:

Procedure: Fat grafting