Back to resultsCan ILR Reduce the Risk of Arm Lymphedema?
Primary Purpose
Breast Cancer Lymphedema
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Immediate lymphatic reconstruction
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer Lymphedema
Eligibility Criteria
Inclusion Criteria: Female patients with unilateral breast cancer Going to receive axillary lymph node dissection, or sentinel lymph node biopsy but being highly suspected of axillary metastasis preoperatively Exclusion Criteria: Had received axillary lymph node dissection Going to receive bilateral axillary lymph node dissections Already have arm lymphedema Allergy to the dye used intraoperatively
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ILR
non-ILR
Arm Description
Breast cancer patients receiving axillary lymph node dissection and immediate lymphatic reconstruction
Breast cancer patients receiving only axillary lymph node dissection
Outcomes
Primary Outcome Measures
Arm lymphedema
Occurrence of arm lymphedema
Secondary Outcome Measures
Drainage amount
Drainage amount from operative wounds
Seroma or lymphocele
Occurrence of seroma or lymphocele
PROM
Patient reported outcome measures by LYMPH-Q Upper Extremity Module
Subclinical lymphedema
Occurrence of subclinical lymphedema
Full Information
NCT ID
NCT05742945
First Posted
February 15, 2023
Last Updated
February 15, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05742945
Brief Title
Can ILR Reduce the Risk of Arm Lymphedema?
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
August 2028 (Anticipated)
Study Completion Date
August 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ILR
Arm Type
Experimental
Arm Description
Breast cancer patients receiving axillary lymph node dissection and immediate lymphatic reconstruction
Arm Title
non-ILR
Arm Type
No Intervention
Arm Description
Breast cancer patients receiving only axillary lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
Immediate lymphatic reconstruction
Intervention Description
Breast cancer patients receive axillary lymph node dissection and immediate lymphatic reconstruction
Primary Outcome Measure Information:
Title
Arm lymphedema
Description
Occurrence of arm lymphedema
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Drainage amount
Description
Drainage amount from operative wounds
Time Frame
Two weeks
Title
Seroma or lymphocele
Description
Occurrence of seroma or lymphocele
Time Frame
One month
Title
PROM
Description
Patient reported outcome measures by LYMPH-Q Upper Extremity Module
Time Frame
Two years
Title
Subclinical lymphedema
Description
Occurrence of subclinical lymphedema
Time Frame
Two years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients with unilateral breast cancer
Going to receive axillary lymph node dissection, or sentinel lymph node biopsy but being highly suspected of axillary metastasis preoperatively
Exclusion Criteria:
Had received axillary lymph node dissection
Going to receive bilateral axillary lymph node dissections
Already have arm lymphedema
Allergy to the dye used intraoperatively
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao-Chih Dai, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Non-identifiable data will be shared upon request
Learn more about this trial
Can ILR Reduce the Risk of Arm Lymphedema?
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