Breast Cancer-Related LymphedemaLAF-ALNDNCT07415200
Pedicled Lateral Chest Wall Lymph-Adipofascial Flap to Prevent Arm Lymphedema After Breast Cancer Surgery
A study testing Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary Reconstruction in people with Breast Cancer-Related Lymphedema and Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Breast cancer surgery that includes removal of lymph nodes from the armpit (axillary lymph node dissection) can disrupt normal lymphatic drainage and may lead to arm swelling, known as lymphedema. This condition can cause discomfort, limit arm function, and reduce quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer-Related Lymphedema, Breast Cancer, Postoperative Complications
- What is being tested?
- Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2026to 1 Mar 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 75 years;
- Histologically confirmed invasive breast cancer;
- Pathologically confirmed axillary lymph node metastasis requiring axillary lymph node dissection;
- Body mass index (BMI) ≥ 25 kg/m²;
- Planned to receive postoperative regional lymph node radiation therapy;
- Ability to understand the study procedures and provide written informed consent;
- Willingness and ability to comply with study follow-up and assessments.
Who cannot join
- Previous surgery involving the ipsilateral axilla;
- Previous radiation therapy to the ipsilateral axilla;
- Evidence of distant metastatic breast cancer;
- Bilateral breast cancer, or a history of contralateral breast cancer surgery;
- Severe hepatic or renal dysfunction, or severe cardiac insufficiency;
- Inability to read or understand Chinese sufficiently to complete study questionnaires and assessments;
- Pregnancy;
- Any condition or circumstance that, in the investigator's judgment, may interfere with study compliance or follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Jiannan Wu, MD, king8702@163.com
Jiannan Wu, MD
About this study
Official title: Efficacy and Safety of Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary Reconstruction for the Prevention of Breast Cancer-Related Arm Lymphedema: A Prospective, Single-Arm, Phase II Clinical Study
Breast cancer surgery that includes removal of lymph nodes from the armpit (axillary lymph node dissection) can disrupt normal lymphatic drainage and may lead to arm swelling, known as lymphedema. This condition can cause discomfort, limit arm function, and reduce quality of life. Patients with a higher body mass index and those who receive regional lymph node radiation are at particularly high risk.
This study aims to evaluate whether a preventive surgical technique, called axillary reconstruction using a pedicled lateral chest wall lymph-adipofascial flap, can reduce the risk of developing arm lymphedema after breast cancer surgery. During standard breast cancer surgery with axillary lymph node dissection, a small flap of tissue containing fat, fascia, and lymphatic tissue from the lateral chest wall is rotated into the axillary area to fill the surgical space and support lymphatic drainage.
This is a prospective, single-arm Phase II clinical study. Participants will be followed for up to 24 months after surgery to assess the occurrence of arm lymphedema, changes in arm volume and bioimpedance measurements, quality of life, and surgery-related complications. The results of this study may help determine whether this simple and widely applicable technique can safely reduce the risk of lymphedema in high-risk breast cancer patients.
Read the detailed description
Breast cancer-related arm lymphedema is a common and long-term complication following breast cancer surgery that includes axillary lymph node dissection. Disruption of lymphatic drainage pathways in the axilla can lead to chronic arm swelling, discomfort, recurrent infections, and impaired quality of life. The risk of lymphedema is particularly high in patients with elevated body mass index and those who require regional lymph node radiation therapy.
Current preventive surgical approaches mainly focus on immediate lymphatic reconstruction using lymphatic-venous anastomosis. Although this technique may reduce early postoperative lymphedema in selected patients, its long-term effectiveness remains uncertain. In addition, the procedure requires microsurgical expertise and specialized equipment, limiting its widespread implementation. A substantial proportion of patients are also not suitable candidates due to the absence of identifiable lymphatic vessels for anastomosis.
An alternative preventive strategy is axillary reconstruction using vascularized lymph-adipofascial tissue. The lateral chest wall contains abundant adipose tissue, deep fascia, and lymphatic networks supplied by reliable perforating vessels. A pedicled lateral chest wall lymph-adipofascial flap can be harvested without microsurgical anastomosis and rotated into the axillary defect created after lymph node dissection. This approach aims to reduce postoperative dead space, modulate fibrosis, and provide a biologically favorable environment that may support lymphatic drainage and tissue remodeling.
This study is a prospective, single-arm Phase II clinical trial designed to evaluate the efficacy and safety of axillary reconstruction using a pedicled lateral chest wall lymph-adipofascial flap in breast cancer patients at high risk for lymphedema. Eligible participants will undergo standard breast cancer surgery with axillary lymph node dissection, followed by immediate axillary reconstruction using the pedicled flap. The procedure adds minimal operative time and does not require microsurgical techniques.
Participants will be followed for up to 24 months after surgery. The study will assess the incidence of postoperative arm lymphedema, longitudinal changes in objective arm measurements, patient-reported quality of life, oncologic outcomes, and surgery-related complications. By focusing on a high-risk population, this study aims to clarify whether this simple and widely applicable surgical technique can safely reduce the burden of lymphedema and improve postoperative recovery after breast cancer surgery.
- Being tested
- Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary Reconstruction
- Keywords
- Breast Cancer-Related Lymphedema, Breast Cancer, Axillary Lymph Node Dissection, Axillary Reconstruction, Preventive Surgery
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary ReconstructionProcedure or surgery
This intervention consists of immediate axillary reconstruction using a pedicled lateral chest wall lymph-adipofascial flap performed at the time of standard axillary lymph node dissection for breast cancer. The flap is harvested from the lateral chest wall based on reliable perforating vessels and includes adipose tissue and deep fascia that contain native lymphatic structures. The flap is rotated into the axillary defect without microsurgical lymphatic or vascular anastomosis and is secured to surrounding tissues to fill the dead space. This technique differs from lymphatic-venous anastomosis-based procedures by avoiding microsurgical reconstruction and is designed to be easily reproducible with minimal additional operative time.
| Study group | Role | What they receive |
|---|---|---|
| Pedicled Lymph-Adipofascial Flap Axillary Reconstruction | Experimental | Participants in this arm will undergo standard breast cancer surgery with axillary lymph node dissection, followed by immediate axillary reconstruction using a pedicled lateral chest wall lymph-adipofascial flap. The flap, containing adipose tissue, deep fascia, and lymphatic structures, is harvested from the lateral chest wall and rotated into the axillary defect without microsurgical anastomosis. This preventive surgical approach is intended to support lymphatic drainage and reduce the risk of postoperative arm lymphedema. Receives: Procedure: Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema-Free Survival of the Operated Arm
The primary outcome is the proportion of participants who remain free of arm lymphedema after surgery. Arm lymphedema is defined by the presence of clinical symptoms or signs consistent with lymphedema together with objective measurement criteria, including a relative volume change of the operated arm or abnormal bioimpedance measurements, as assessed during follow-up.
Measured: Up to 24 months after surgery
Secondary outcomes (9)
Lymphedema-Free Survival of the Operated Arm at 6 and 12 Months
The proportion of participants who remain free of arm lymphedema at 6 and 12 months after surgery, based on clinical assessment and objective arm measurements performed during follow-up.
Measured: 6 months and 12 months after surgery
Change in Relative Arm Volume
Change in relative arm volume of the operated arm compared with baseline, measured using standardized objective methods and assessed at multiple postoperative time points.
Measured: Baseline, 6 months, 12 months, and 24 months after surgery
Lymphedema-Specific Quality of Life (LLIS)
Change from baseline in patient-reported lymphedema-related quality of life, assessed using the Lymphedema Life Impact Scale (LLIS).
Measured: Baseline, 6 months, 12 months, and 24 months after surgery
Overall Quality of Life (EORTC QLQ-C30)
Change from baseline in overall quality of life, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Measured: Baseline, 6 months, 12 months, and 24 months after surgery
Breast Cancer-Specific Quality of Life (EORTC QLQ-BR23)
Change from baseline in breast cancer-specific quality of life, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23).
Measured: Baseline, 6 months, 12 months, and 24 months after surgery
Local Recurrence-Free Survival (LRFS)
Local recurrence-free survival is defined as the time from the date of surgery to the first documented local recurrence in the ipsilateral axilla, as confirmed by imaging studies or pathological examination.
Measured: Up to 24 months after surgery
Regional Recurrence-Free Survival (RRFS)
Regional recurrence-free survival is defined as the time from the date of surgery to the first documented recurrence in regional lymph node areas, including the supraclavicular, or internal mammary lymph nodes, confirmed by imaging studies or pathological examination.
Measured: Up to 24 months after surgery
Overall Survival (OS)
Overall survival, defined as the time from surgery to death from any cause.
Measured: Up to 24 months after surgery
Surgery-Related Complications
Incidence of surgery-related complications, including but not limited to postoperative bleeding, flap-related complications (such as fat necrosis or flap necrosis), wound infection, and postoperative seroma, assessed during the postoperative period.
Measured: Up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start20 Feb 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer-Related LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415200
- Sponsor's protocol ID
- SYSKY-2026-001-02
- Acronym
- LAF-ALND
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The data collected will be used solely for the purposes of this study and related scientific publications.