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

NCT07023796 | Completed DMC

• 1 other identifier: R-2023-1301-147
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

Autologus Fat Filtration; Radiodermatitis; Breast cancer; Nanofat

Outcome Measures

Primary Outcomes (1)

• Number of patients with radiodermatitis

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

  From the start to six week later

Study Arms (2)

Patients who received general care

NO INTERVENTION

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

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

Procedure: Autologous fat filtration

Interventions

Autologous fat filtration PROCEDURE

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

Patients who received autologous fat filtration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Belisario Dominguez 1000

Guadalajara, Jalisco, 44329, Mexico

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 17, 2025
• Study Start: September 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)