LymphedemaLYMPHANCT04687956
Primary Surgical Prevention of Breast Cancer-related Lymphedema
A study testing LYMPHA in people with Lymphedema and Mastectomy, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lymphedema, Mastectomy, Breast Cancer
- What is being tested?
- LYMPHA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, 06273
Soong June Bae, M.D., 82-2-2019-4401, mission815815@yuhs.ac
About this study
Official title: Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for 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.
Read the 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.
- Conditions
- Lymphedema, Mastectomy, Breast Cancer
- Being tested
- LYMPHA, control
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYMPHAProcedure or surgery
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.
controlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| LYMPHA | Experimental | LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches. Receives: Procedure: LYMPHA |
| Control | Active comparator | No LYMPHA procedure is performed Receives: Procedure: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of lymphedema
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.
Measured: 2 years after surgery
Secondary outcomes (5)
UEL index
To compare the UEL index
Measured: 2 years after surgery
Changes in Lymphoscintigraphy
To compare the changes in lymphoscintigraphy presented by the change of transport index (TI)
Measured: 2 years after surgery
Incidence of lymphedema
To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery.
Measured: 5 years after surgery
5-year recurrence rate
To compare the recurrence rate
Measured: 5 years after surgery
5-year overall survival rate
To compare the overall survival rate
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Feb 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Jeong, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687956
- Sponsor's protocol ID
- 3-2020-0343
- Acronym
- LYMPHA
- Status last verified
- Oct 2023
- First submitted
- 29 Nov 2020
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema
- ClinicalTrials.gov ID
- NCT04687956
- Acronym / sponsor ID
- LYMPHA / 3-2020-0343
- Conditions
- Lymphedema, Mastectomy, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LYMPHA | Experimental | Procedure: LYMPHALYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches. |
| Control | Active comparator | Procedure: controlNo LYMPHA procedure is performed |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYMPHAAxillary 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. | Procedure or surgery | LYMPHA |
| controlIn 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. | Procedure or surgery | Control |
Primary outcome
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.
5 secondary outcomes
UEL index
Time frame: 2 years after surgery
Changes in Lymphoscintigraphy
Time frame: 2 years after surgery
Incidence of lymphedema
Time frame: 5 years after surgery
5-year recurrence rate
Time frame: 5 years after surgery
5-year overall survival rate
Time frame: 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LYMPHA in people with Lymphedema and Mastectomy, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soong June Bae, M.D. (82-2-2019-4401, mission815815@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of lymphedema (time frame: 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.