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

Not Applicable

Completed

• Conditions: Breast Cancer; Radio Dermatitis; Radiotherapy

• Registration Number: NCT07023796
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of patients with radiodermatitis	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.

Trial Locations

Locations (1)

Belisario Dominguez 1000; 🇲🇽 Guadalajara, Jalisco, Mexico