Can ILR Reduce the Risk of Arm Lymphedema?

Breast Cancer Lymphedema Clinical Trial

Official title:

Can Immediate Lymphatic Reconstruction With Lymphatico-Venous Anastomosis Reduce the Occurrence of Arm Lymphedema in Breast Cancer Patients After Axillary Lymph Node Dissection? A Prospective Randomized Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05742945
• Other study ID #: 202207198RINB
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: August 2028

Study information

• Verified date: March 2024
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Breast cancer-related lymphedema (BCRL) is a debilitating, usually lifelong burden for breast cancer survivors. For the breast cancer patients receiving axillary lymph node dissection (ALND), the likelihood of BCRL is about 20%. Lymphatico-venous anastomosis (LVA) has been accepted as a method of treating extremity lymphedema. A few studies have mentioned the prophylactic effect of LVA on BCRL. However, there is still lack of a large-scale randomized controlled trial to corroborate its efficacy. Therefore, the goal of this study is to conduct a prospective randomized controlled trial to evaluate if immediate lymphatic reconstruction (ILR) with LVA could have a clinically significant effect on the reduction of BCRL occurrence.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: August 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Female patients with unilateral breast cancer

2. Going to receive axillary lymph node dissection, or sentinel lymph node biopsy but being highly suspected of axillary metastasis preoperatively

Exclusion Criteria:

1. Had received axillary lymph node dissection

2. Going to receive bilateral axillary lymph node dissections

3. Already have arm lymphedema

4. Allergy to the dye used intraoperatively

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Procedure:
• Immediate lymphatic reconstruction
Breast cancer patients receive axillary lymph node dissection and immediate lymphatic reconstruction

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm lymphedema	Occurrence of arm lymphedema	Two years
Secondary	Drainage amount	Drainage amount from operative wounds	Two weeks
Secondary	Seroma or lymphocele	Occurrence of seroma or lymphocele	One month
Secondary	PROM	Patient reported outcome measures by LYMPH-Q Upper Extremity Module	Two years
Secondary	Subclinical lymphedema	Occurrence of subclinical lymphedema	Two years