RecruitingPhase 2

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

A Pilot 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two ways to guide arm massage for fluid buildup called lymphedema: a dye-based map of fluid drainage paths and the usual method. It looks at whether the mapped method is practical and whether patients follow it. The study is for adults having underarm lymph nodes removed to treat breast cancer.

Breast cancer is estimated to affect approximately 300,000 women in the US in 2023. Studies demonstrate that 1 in 5 will develop breast cancer related lymphedema secondary to the treatments that they receive. BCRL at this time has no cure, however early detection can prevent the progression to late stage BCRL. At this time a technique of arm massage, manual lymphatic drainage (MLD), is used for treatment. This study investigates a new method of MLD, which is guided by the individual patients' lymphatic anatomy through use of ICG-lymphography.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have breast cancer in stages Tis–T4N0–3M0, with no spread to distant parts of the body.
  • Be having underarm lymph nodes removed, with or without surgery to rebuild fluid drainage paths.
  • Have an ICG dye map of fluid drainage paths and a physical therapy exam before surgery. If you had chemotherapy before surgery, have a swelling check with physical therapy after chemotherapy ends.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have no more than one active cancer, unless the treating doctor and study leader agree another cancer will not affect study safety or results.
  • Sign a consent form and agree to follow all study procedures.
  • If you can become pregnant, have a negative pregnancy test before joining and use birth control during the study. Receive advice about avoiding pregnancy and its possible risks.

Who can't join

  • Have had breast cancer on the side being treated, or have current or past breast cancer on the other side. Have had underarm surgery on either side, or plan to have it on the other side.
  • Have current or past cancer in the arm on the side being treated, such as skin cancer.
  • Have had swelling or poor fluid drainage in either arm, or have drainage problems found before surgery. Have had an arm blood clot or an infection of the skin or fluid drainage vessels.
  • Have heart failure or serious heart disease, including a pacemaker that cannot be used with the study’s electrical body-fluid test. Have signs of liver problems, including end-stage liver disease.
  • Have fewer than 10 lymph nodes removed without chemotherapy before surgery, or fewer than 8 with it. These totals include nodes removed during a sentinel lymph node biopsy.
  • Have missing notes about what was found and done during the underarm surgery.
  • Be pregnant or breastfeeding, or have another health problem that the doctor believes makes study treatment unsafe or study results hard to judge.
  • Be a prisoner, be held against your will, or be required to stay for treatment of a mental or physical illness.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (1)

FL