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Primary Surgical Prevention of Breast Cancer-related Lymphedema (LYMPHA)

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ClinicalTrials.gov Identifier: NCT04687956
Recruitment Status : Not yet recruiting
First Posted : December 29, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Joon Jeong, Gangnam Severance Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphedema Mastectomy Breast Cancer Procedure: LYMPHA Procedure: control Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LYMPHA
LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.
 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.
Active Comparator: Control
No LYMPHA procedure is performed
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of lymphedema [ Time Frame: 2 years after surgery ]
    To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.


Secondary Outcome Measures :
  1. UEL index [ Time Frame: 2 years after surgery ]
    To compare the UEL index

  2. Changes in Lymphoscintigraphy [ Time Frame: 2 years after surgery ]
    To compare the changes in lymphoscintigraphy presented by the change of transport index (TI)

  3. Incidence of lymphedema [ Time Frame: 5 years after surgery ]
    To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery.

  4. 5-year recurrence rate [ Time Frame: 5 years after surgery ]
    To compare the recurrence rate

  5. 5-year overall survival rate [ Time Frame: 5 years after surgery ]
    To compare the overall survival rate


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patient
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Joon Jeong, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT04687956    
Other Study ID Numbers: 3-2020-0343
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes