Autologous Fat Infiltration Versus General Measures as Treatment in Radiodermatitis Induced for Radiotherapy in Breast Cancer Patients

Instituto Mexicano del Seguro Social

Status: Completed

Conditions: Breast Cancer; Radiotherapy; Radio Dermatitis

Treatments: Procedure: Autologous fat filtration

Study type: Interventional

Funder types: Other

Identifiers

NCT07023796

R-2023-1301-147

Details and patient eligibility

About

Radiodermatitis is a major problem in oncologic patients, fat grafts previously used for cosmetic procedures have been shown to have regenerative power due to their stem cell content. Our purpose was to compare the clinical changes in the treatment of radiation dermatitis in breast cancer patients with the application of fat graft versus traditional therapy with general measures.A randomized controlled clinical trial was performed, 22 patients were recruited and randomly assigned to one of two groups: an intervention group that received an autologous fat graft and a control group that received treatment with general measures; a 6-week follow-up was performed to determine the presence and classification of radiodermatitis using the LENT/SOMA scales, as well as biopsies. Women were included, with a diagnosis of breast cancer, Eastern Cooperative Oncology Group 0 or 1, attended in our hospital during September 2023 to October 2024, older than 18 years, undergoing lumpectomy or mastectomy and in radiotherapy as part of the treatment scheme for breast cancer.

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients older than 18 years with a confirmed diagnosis of common bile duct cyst by imaging studies and/or intraoperative findings.
• Patients who received surgical treatment at the institution during the study period.
• Clinical records with complete information for analysis.

Exclusion criteria

• Patients who do not consent to their inclusion in the study or who for any physical or mental reason are unable to give their consent (patients with cognitive impairment, etc.).
• Pediatric patients (<18 years).
• Incomplete clinical records or with loss of postoperative follow-up.
• Patients with diagnosis of other biliary pathology without evidence of common bile duct cyst.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Patients who received general care

No Intervention group

Description:

Patients who received daily skin washing with warm water and mild soap (pH neutral, fragrance free) without scrubbing.

Patients who received autologous fat filtration

Active Comparator group

Description:

Patients who underwent a surgical procedure and autologous fat processing for subsequent fat filtration.

Treatment:

Procedure: Autologous fat filtration