Can a Dye-Guided massage stop arm swelling in breast cancer patients?
NCT ID NCT06327490
First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This study tests whether using a special dye (ICG) to map the arm's lymph vessels can make daily arm massage more effective at preventing lymphedema (swelling) after breast cancer surgery. 30 women will be randomly assigned to either ICG-guided massage or traditional massage, and researchers will track how often they do the massage and how much their arm swells over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Indocyanine green (ICG) injection for lymphatic mapping, followed by manual lymphatic drainage (arm massage) guided by the images
- What this could lead to
- If it works, this could provide a more effective way to prevent or reduce arm swelling after breast cancer surgery, improving quality of life.
- What could go wrong
- This is a small pilot study with only 30 participants, so results may not apply to everyone. The benefit of ICG-guided massage over traditional massage is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Florida
RECRUITINGGainesville, Florida, 32610, United States
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