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NCT Number: NCT04687956

Primary Surgical Prevention of Breast Cancer-related Lymphedema

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.

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Key information

Conditions

Lymphedema Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Mastectomy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, 06273, South Korea

Location status: Recruiting

Location contact

Soong June Bae, M.D.

CONTACT

[email protected]

82-2-2019-4401

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LYMPHA

Procedure

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.

Control

Procedure

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Soong June Bae, M.D.

CONTACT

[email protected]

82-2-2019-4401

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema

Acronym: LYMPHA

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2020
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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