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

NCT ID: NCT07023796

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-10-31

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.

Conditions

Breast Cancer; Radio Dermatitis; Radiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients who received general care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Patients who received autologous fat filtration

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

Group Type: ACTIVE_COMPARATOR

Autologous fat filtration

Intervention Type: PROCEDURE

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

Interventions

Autologous fat filtration

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: lead

Responsible Party

Clotilde Fuentes-Orozco

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Belisario Dominguez 1000

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

R-2023-1301-147

Identifier Type: -

Identifier Source: org_study_id