30 Participants Needed

ICG-Guided vs. Traditional Lymphatic Drainage for Breast Cancer

JW
Overseen ByJudy Walsh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ICG-guided manual lymphatic drainage for breast cancer?

Research shows that manual lymphatic drainage (MLD) can improve the quality of life in patients with chronic venous disease and is used in breast cancer-related lymphedema. Indocyanine green (ICG) lymphography helps guide personalized MLD, which has been integrated into clinical practice to manage lymphedema effectively.12345

What makes ICG-guided manual lymphatic drainage unique compared to traditional methods for breast cancer treatment?

ICG-guided manual lymphatic drainage uses indocyanine green (ICG) to provide real-time fluorescent imaging, which helps in accurately mapping lymphatic pathways and potentially improving the effectiveness of lymphatic drainage compared to traditional methods that do not use this imaging technique.56789

What is the purpose of this trial?

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.

Research Team

LS

Lisa Spiguel, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for breast cancer patients undergoing axillary node dissection. It's designed to see if a new type of manual lymphatic drainage (MLD) guided by indocyanine-green (ICG) imaging can help prevent lymphedema, which is swelling due to fluid build-up after breast cancer treatment.

Inclusion Criteria

I am fully active or can carry out light work.
Subjects of childbearing potential 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
I will have a physical therapy evaluation before my lymph node surgery.
See 4 more

Exclusion Criteria

I have had surgery on the same side's armpit area before.
Patients who are confirmed to be pregnant or breastfeeding
I am scheduled for or have had surgery on the opposite underarm area.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive manual lymphatic drainage (MLD) guided by either ICG-lymphography or traditional methods

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • ICG-guided manual lymphatic drainage
  • Traditional manual lymphatic drainage
Trial Overview The study compares two MLD techniques in preventing lymphedema: the new ICG-guided method that uses special imaging to tailor the massage to each patient's unique lymphatic system, and the traditional approach without such guidance.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ICG-guided manual lymphatic drainageExperimental Treatment2 Interventions
Group II: Traditional manual lymphatic drainageActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Findings from Research

In a study involving 457 patients, manual lymphatic drainage (MLD) did not show a significant overall reduction in upper extremity edema compared to no treatment, indicating its efficacy remains uncertain.
However, when patients received 20 or more MLD sessions or underwent treatment for more than 2 weeks, there was a significant reduction in limb volume, suggesting that the effectiveness of MLD may depend on the treatment duration and frequency.
Effect of Manual Lymphatic Drainage on Breast Cancer-Related Postmastectomy Lymphedema: A Meta-analysis of Randomized Controlled Trials.Qiao, J., Yang, LN., Kong, YH., et al.[2023]
Manual lymphatic drainage (MLD) significantly reduces pain intensity in breast cancer-related lymphedema (BCRL) patients, based on a meta-analysis of 11 randomized controlled trials involving 1564 participants.
While MLD shows promise in reducing the incidence of lymphedema, it does not significantly improve volumetric changes of lymphedema or quality of life for patients.
Manual Lymphatic Drainage for Breast Cancer-related Lymphedema: A Systematic Review and Meta-analysis of Randomized Controlled Trials.Lin, Y., Yang, Y., Zhang, X., et al.[2022]
A study of 339 patients with cancer-related lymphedema revealed that ICG lymphography effectively identifies compensatory drainage patterns, which can inform personalized treatment plans.
In upper limb lymphedema, the majority of patients (74.9%) showed drainage to the ipsilateral axilla, while in lower limb cases, the most common drainage site was the ipsilateral inguinal region (52.3%), highlighting the importance of targeted manual lymphatic drainage techniques based on these patterns.
Personalizing Conservative Lymphedema Management Using Indocyanine Green-Guided Manual Lymphatic Drainage.Koelmeyer, LA., Thompson, BM., Mackie, H., et al.[2021]

References

Effect of Manual Lymphatic Drainage on Breast Cancer-Related Postmastectomy Lymphedema: A Meta-analysis of Randomized Controlled Trials. [2023]
Manual Lymphatic Drainage for Breast Cancer-related Lymphedema: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2022]
Personalizing Conservative Lymphedema Management Using Indocyanine Green-Guided Manual Lymphatic Drainage. [2021]
Manual lymphatic drainage improves the quality of life in patients with chronic venous disease: a randomized controlled trial. [2021]
Novel Dual Tracer Indocyanine Green and Radioisotope Versus Gold Standard Sentinel Lymph Node Biopsy in Breast Cancer: The GREENORBLUE Trial. [2023]
Fluorescent lymphography for thoracic duct identification: Initial experience of a simplified and feasible ICG administration. [2022]
A Randomized Prospective Non-Inferiority Trial of Sentinel Lymph Node Biopsy in Early Breast Cancer: Blue Dye Compared with Indocyanine Green Fluorescence Tracer. [2022]
Diagnostic Performance of Indocyanine Green Plus Methylene Blue Versus Radioisotope Plus Methylene Blue Dye Method for Sentinel Lymph Node Biopsy in Node-Negative Early Breast Cancer. [2021]
Breast cancer sentinel lymph node mapping using near-infrared guided indocyanine green in comparison with blue dye. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security