Breast Cancer, Radio Dermatitis, Radiotherapy
Conditions
Keywords
Autologus Fat Filtration, Radiodermatitis, Breast cancer, Nanofat
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.
Interventions
PROCEDUREAutologous fat filtration
Patients who underwent a surgical procedure and autologous fat processing for subsequent fat filtration.
Sponsors
Instituto Mexicano del Seguro Social
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Mexico
Outcome results
None listed