Trials / Completed
CompletedNCT07023796
Autologous Fat Infiltration Versus General Measures as Treatment in Radiodermatitis Induced for Radiotherapy in Breast Cancer Patients
Comparison of the Efficacy Between Autologous Fat Infiltration and Treatment With General Measures in the Management of Radiotherapy-induced Radiodermatitis in Breast Cancer Patients.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Instituto Mexicano del Seguro Social · Other Government
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Autologous fat filtration | Patients who underwent a surgical procedure and autologous fat processing for subsequent fat filtration. |
Timeline
- Start date
- 2023-09-01
- Primary completion
- 2024-10-31
- Completion
- 2024-10-31
- First posted
- 2025-06-17
- Last updated
- 2025-06-17
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT07023796. Inclusion in this directory is not an endorsement.