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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Dermatitis Neoplasms Neoplasms by Site Radiation Injuries Radio Dermatitis Radiodermatitis Radiotherapy Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Belisario Dominguez 1000

Guadalajara, Jalisco, 44329, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous fat filtration

Procedure

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

Primary outcomes

Number of patients with radiodermatitis

Time frame: From the start to six week later

The number of patients with radiodermatitis secondary to radiotherapy will be measured from the day they received the treatment until six weeks later.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Comparison of the Efficacy Between Autologous Fat Infiltration and Treatment With General Measures in the Management of Radiotherapy-induced Radiodermatitis in Breast Cancer Patients.

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jun 17, 2025
Registry last updated: Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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