To Assess the Efficacy of the LYMPHA in the Prevention of Lymphedema Following Axillary Dissection for Breast Cancer (LYMPHA)

March 13, 2021 updated by: Pusan National University Hospital

A Randomized Controlled Trial to Assess the Efficacy of the Lymphatic Microsurgical Preventive Healing Approach (LYMPHA) to Prevent Lymphedema After Axillary Dissection for Breast Cancer

Lymphedema is the Build-up of Lymph Fluid in the Body's Tissue Causing Chronic, Debilitating Swelling. This Commonly Occurs as a Result of a Disruption of the Lymphatic System During Lymph Node Dissection Surgeries. LYMPHA (LYmphatic Microsurgical Preventive Healing Approach) is an Innovative Microsurgical Technique Where Blocked Lymphatic Vessels Are Drained Into the Blood Circulation by Surgically Creating a Shunt Between a Lymphatic Channel and a Blood Vessel Called a Lymphatic-venous Bypass. Recently, LYMPHA Technique Has Been Shown to Prevent Lymphedema When Performed at the Time of Nodal Dissection. We Propose a Prospective Study Evaluating the Effectiveness of LYMPHA Technique Using Objective Clinical Protocol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Consenting patients will have the LYMPHA procedure at the time of planned axillary dissection surgery for the prevention of upper and extremity lymphedema. The node dissection will be performed by Dr. Kang while the LYMPHA technique will be performed by the plastic surgeon, Dr. Kim. The LYMPHA procedure consist of performing LVA at the time of the node dissection. Patent blue dye will be injected in the volar surface of the upper third of the arm in a quantity of about 1-2 ml intradermally, subcutaneously, and under muscular fascia into patient approximately 10 minutes before skin incision. This will allow mapping of the lymphatic channels for identification for bypass. The node dissection will then be performed with preservation of the anterior branch of the axillary vein in the axilla. Afferent lymphatic vessels will be sutured into a branch of the axillary vein distal to a competen valve. The total duration of the surgery is approximately 3 hours. The LYMPHA technique accounts for an additional 30 min to the standard 2-2.5 hours allocated to the node dissection.

Pre-surgery, patients will have baseline limb circumference measurements of both the surgery-affected and unaffected arms and by lymphoscintigraphy. Patients will be followed up clinically at every 6 months up to a year. At each follow-up visit, patients will have a physical examination and their circumference of their limbs taken. Patients will also fill out a LyQLI, SF-36, DASH administered by the Clinical Research Coordinator pre-and post-surgery. Each patient will have a total of 1 years of participation time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
    • Seo-Gu
      • Busan, Seo-Gu, Korea, Republic of, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Node-positive cancer requiring an axillary or lymphadenectomy
  • Below 30 Body Mass Index

Exclusion Criteria:

  • Patients receiving a sentinel lymph node biopsy
  • Patients with established preoperative lymphedema
  • Patients with post-thrombotic syndrome, peripheral vascular disease
  • Pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LYMPHA technique group
LVA at the time of Axillary Dissection
Procedure: LYMPHA(LYmphatic Microsurgical Preventive Healing Approach) technique
Patients will receive a lymphatic-venous anastomosis at time of their required Axillary Dissection
No Intervention: Non-LYMPHA technique group
No preventive surgical approach

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
lymphatic flow
Time Frame: 6 months
Difference in lymphatic flow between LYMPHA technique group and Non-LYMPHA technique group
6 months
limb volume
Time Frame: 6 months
Difference in limb volume between LYMPHA technique group and Non-LYMPHA technique group
6 months
lymphatic flow
Time Frame: 1 year
Difference in lymphatic flow between LYMPHA technique group and Non-LYMPHA technique group
1 year
limb volume
Time Frame: 1 year
Difference in limb volume between LYMPHA technique group and Non-LYMPHA technique group
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pusan National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-1912-010-086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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