Primary Surgical Prevention of Breast Cancer-related Lymphedema (LYMPHA)
Primary Purpose
Lymphedema, Mastectomy, Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LYMPHA
control
Sponsored by
About this trial
This is an interventional prevention trial for Lymphedema
Eligibility Criteria
Inclusion Criteria:
- Age over 19 years old
- 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:
- Patients with vascular and lymph-related diseases
- Patients with a history of surgical treatment or trauma to both arms and axillary
- Patients with a history of receiving radiation treatment in both arms, chest, and axilla
- Patients with confirmed systemic metastasis with stage 4 breast cancer
- Pregnant and lactating patients
Sites / Locations
- Gangnam Severance Hospital, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LYMPHA
Control
Arm Description
LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.
No LYMPHA procedure is performed
Outcomes
Primary Outcome Measures
Incidence of lymphedema
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.
Secondary Outcome Measures
UEL index
To compare the UEL index
Changes in Lymphoscintigraphy
To compare the changes in lymphoscintigraphy presented by the change of transport index (TI)
Incidence of lymphedema
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery.
5-year recurrence rate
To compare the recurrence rate
5-year overall survival rate
To compare the overall survival rate
Full Information
NCT ID
NCT04687956
First Posted
November 29, 2020
Last Updated
October 9, 2023
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04687956
Brief Title
Primary Surgical Prevention of Breast Cancer-related Lymphedema
Acronym
LYMPHA
Official Title
Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Mastectomy, Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LYMPHA
Arm Type
Experimental
Arm Description
LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
No LYMPHA procedure is performed
Intervention Type
Procedure
Intervention Name(s)
LYMPHA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of lymphedema
Description
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.
Time Frame
2 years after surgery
Secondary Outcome Measure Information:
Title
UEL index
Description
To compare the UEL index
Time Frame
2 years after surgery
Title
Changes in Lymphoscintigraphy
Description
To compare the changes in lymphoscintigraphy presented by the change of transport index (TI)
Time Frame
2 years after surgery
Title
Incidence of lymphedema
Description
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery.
Time Frame
5 years after surgery
Title
5-year recurrence rate
Description
To compare the recurrence rate
Time Frame
5 years after surgery
Title
5-year overall survival rate
Description
To compare the overall survival rate
Time Frame
5 years after surgery
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Female patient
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 19 years old
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:
Patients with vascular and lymph-related diseases
Patients with a history of surgical treatment or trauma to both arms and axillary
Patients with a history of receiving radiation treatment in both arms, chest, and axilla
Patients with confirmed systemic metastasis with stage 4 breast cancer
Pregnant and lactating patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soong June Bae, M.D.
Phone
82-2-2019-4401
Email
mission815815@yuhs.ac
Facility Information:
Facility Name
Gangnam Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soong June Bae, M.D.
Phone
82-2-2019-4401
Email
mission815815@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Primary Surgical Prevention of Breast Cancer-related Lymphedema
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