Primary Surgical Prevention of Breast Cancer-related Lymphedema

Breast Cancer Clinical Trial

— LYMPHA  

Official title:

Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04687956
• Other study ID #: 3-2020-0343
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Gangnam Severance Hospital
• Contact: Soong June Bae, M.D.
• Phone: 82-2-2019-4401
• Email: mission815815[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.

Description:

Patients in the LYMPHA group undergo Axillary reverse mapping before the start of surgery, and after axillary lymph node resection, LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Mastectomy

Intervention

Procedure:
• LYMPHA
Axillary reverse mapping is performed before surgery, axillary lymph node resection is performed, and 'LYMPHA' (Lymphatic microsurgical preventing healing approach) is performed, and the surgery is terminated. Subsequently, the occurrence of lymphedema is followed up.
• control
In the control group, axillary lymph node resection is performed and the surgery is terminated without additional procedures. Subsequently, the occurrence of lymphedema is followed up.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of lymphedema	To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.	2 years after surgery
Secondary	UEL index	To compare the UEL index	2 years after surgery
Secondary	Changes in Lymphoscintigraphy	To compare the changes in lymphoscintigraphy presented by the change of transport index (TI)	2 years after surgery
Secondary	Incidence of lymphedema	To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery.	5 years after surgery
Secondary	5-year recurrence rate	To compare the recurrence rate	5 years after surgery
Secondary	5-year overall survival rate	To compare the overall survival rate	5 years after surgery