Preventing lymphedema after breast cancer surgery
Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema
This study is testing a new procedure to see if connecting lymph vessels can help prevent swelling in the arm for women having surgery for breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04687956 on ClinicalTrials.gov |
What this trial studies
This study investigates the LYMPHA procedure, which aims to prevent lymphedema in patients undergoing axillary lymph node dissection for breast cancer. The procedure involves connecting lymphatic vessels from the arm to the axillary vein to enhance lymphatic drainage. Patients will be monitored to assess the effectiveness of this approach in reducing lymphedema incidence and improving quality of life. The study will analyze outcomes prospectively to inform clinical practice.
Who should consider this trial
Good fit: Ideal candidates are women over 19 years old who are scheduled for surgery due to breast cancer and require axillary lymph node dissection.
Not a fit: Patients with vascular or lymph-related diseases, prior trauma or surgery to the arms or axilla, or those with stage 4 breast cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of lymphedema in breast cancer patients, improving their quality of life.
How similar studies have performed: While the LYMPHA procedure is a novel approach, similar microsurgical techniques have shown promise in reducing lymphedema in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age over 19 years old 2. Patients who are expected to undergo surgery under the diagnosis of breast cancer, and are determined to undergo axillary lymph node dissection before surgery. Exclusion Criteria: 1. Patients with vascular and lymph-related diseases 2. Patients with a history of surgical treatment or trauma to both arms and axillary 3. Patients with a history of receiving radiation treatment in both arms, chest, and axilla 4. Patients with confirmed systemic metastasis with stage 4 breast cancer 5. Pregnant and lactating patients
Where this trial is running
Seoul
- Gangnam Severance Hospital, Yonsei University College of Medicine — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Soong June Bae, M.D.
- Email: mission815815@yuhs.ac
- Phone: 82-2-2019-4401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.