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Trial Title:
Can ILR Reduce the Risk of Arm Lymphedema?
NCT ID:
NCT05742945
Condition:
Breast Cancer Lymphedema
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Immediate lymphatic reconstruction
Description:
Breast cancer patients receive axillary lymph node dissection and immediate lymphatic
reconstruction
Arm group label:
ILR
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Start date:
February 14, 2023
Completion date:
August 2028
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05742945
