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Study on Manual Lymphatic Drainage for Breast Cancer-Related Lymphedema

This study is looking at two ways to perform manual lymphatic drainage (MLD), a type of arm massage, for people who have had surgery for breast cancer. One group will use a traditional MLD technique. The other group will use a new method called ICG-guided MLD, where indocyanine green (ICG) dye helps map your lymphatic pathways to guide the massage. All participants will receive an injection of indocyanine green for mapping. The study wants to see how well people follow each MLD technique for two years after surgery. You may be able to join if you are an adult (18-99 years old) having axillary lymph node dissection for breast cancer (stages Tis-T4N0-3M0) and have had ICG lymphatic mapping before surgery. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This interventional study plans to enroll 30 participants to compare two different manual lymphatic drainage techniques.
What's involved
Participants will perform manual lymphatic drainage on their affected arm once daily for 2 years post-surgery. All participants will also receive an injection of indocyanine green for lymphatic mapping.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, subject compliance, will be measured at 2 years after surgery.

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NCT06327490

A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer

Recruiting
PHASE2Ages 18–99InterventionalTreatment
University of Florida
~30 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:ICG-guided manual lymphatic drainageTraditional manual lymphatic drainageIndocyanine green

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subject compliance
Measured over 2 years

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Lisa Spiguel, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Stephanie Portillo
[email protected]
352-273-3650
Email the study team

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Eligibility criteria

Inclusion

Adults ≥ 18 years of age
Patients undergoing axillary lymph node dissection with or without lymphatic reconstruction at diagnosis
Patients must have ICG lymphatic mapping performed prior to axillary lymph node dissection
A clinical diagnosis consistent with stage Tis-T4N0-3M0 breast cancer.
ECOG Performance Status of 0-1
Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included).
Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
Subjects of childbearing potential (SOCBP) must have a negative pregnancy test prior to enrollment and be using an adequate method of contraception to avoid pregnancy throughout study participation to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
Patients must undergo a baseline physical therapy evaluation prior to axillary lymph node dissection.
Patients who have received neoadjuvant chemotherapy are required to see physical therapy for lymphedema assessment following completion of chemotherapy prior to surgery.

Exclusion

Patients with history of ipsilateral breast cancer (invasive or ductal carcinoma in situ (DCIS))
Patients with history of prior ipsilateral axillary surgery, such as excisional biopsy of lymph nodes or treatment of benign axillary disease processes such as hidradenitis
Patients with history of or concurrent diagnosis of contralateral breast cancer (bilateral breast cancer)
Patients with planned contralateral axillary surgery or history of contralateral axillary surgery
Patients with a history, or concurrent, malignancy of the ipsilateral upper extremity- i.e. skin cancer
Patients with history of lymphedema or lymphatic dysmotility of the ipsilateral or contralateral arm or are found to have lymphatic dysfunction at their pre-operative visit
Patients with history of upper extremity blood clot, lymphangitis/cellulitis
Patients with history of congestive heart failure or significant cardiac disease (such as New York Heart Association Class III or greater cardiac disease) including pacemakers incompatible for bioimpedance
Patients with evidence of liver dysfunction including diagnosis of end stage liver disease
Patients with less than 10 lymph nodes removed if no neoadjuvant chemotherapy (NAC) received, or less than 8 lymph nodes if NAC received. These node counts include nodes harvested as part of sentinel lymph node biopsy
There is a lack of description of intraoperative findings during axillary lymph node dissection, such as the absence of notes on anatomy and procedure.
Patients who are confirmed to be pregnant or breastfeeding.
History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

What this trial measures

  • Subject compliance2 years

    Determine subject compliance rate with daily manual lymphatic drainage regimen. A subject is considered to be compliant if they perform manual lymphatic drainage at least 3 days/week.