Breast cancer related lymphedema
Conditions
Interventions
Single-arm intervention group:Pedicled lateral chest wall lymph-adipofascial flap axillary reconstruction performed immediately after standard axillary lymph node dissection (ALND), without microsurgi
Sponsors
Sun Yat-sen memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients aged >=18 and =25 kg/m^2; 3. Histopathologically confirmed invasive breast cancer prior to surgery; 4. Pathologically confirmed axillary lymph node metastasis requiring axillary lymph node dissection (ALND); 5. Planned postoperative regional nodal irradiation (RNI); 6. Good compliance with the planned treatment and follow-up, ability to understand the study procedures, and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous surgery to the ipsilateral axilla; 2. Previous radiotherapy to the ipsilateral axilla; 3. Breast cancer with distant metastasis; 4. Bilateral breast cancer, or a history of contralateral breast cancer surgery; 5. Severe hepatic or renal dysfunction, or severe cardiac insufficiency; 6. Inability to read or understand basic Chinese and inability to complete questionnaire assessments; 7. Pregnancy; 8. Any other conditions or serious diseases that may affect compliance, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lymphedema-free survival rate of the affected upper limb within 24 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lymphedema-free rate of the affected upper limb at 6 and 12 months after surgery;;Changes in relative volume change (RVC) of the affected upper limb from baseline at 6, 12, and 24 months postoperatively;Changes in the lymphedema index (L-Dex) of the affected upper limb from baseline at 6, 12, and 24 months postoperatively;Changes from baseline in patient-reported outcomes, including the Lymphedema Life Impact Scale (LLIS) and the EORTC QLQ-C30/BR23 questionnaire scores at 6, 12, and 24 months postoperatively;Oncologic outcomes during the 24-month follow-up period, including axillary local recurrence-free survival (LRFS), regional recurrence-free survival (RRFS), and overall survival (OS) at 6, 12, and 24 months.;Oncology safety indicators: local recurrence rate, regional recurrence rate and distant metastasis rate;Surgical safety indicators: The incidence of adverse events (AEs), serious adverse events (SAEs), and surgery-related complications; | — |
Countries
China
Contacts
Public ContactWu Jiannan
Sun Yat-sen memorial Hospital, Sun Yat-sen University
Outcome results
None listed