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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06327490
• Other study ID #: UF-BRE-012
• Secondary ID: IRB202400626OCR4
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: June 2028

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adults = 18 years of age

• Patients undergoing axillary lymph node dissection with or without lymphatic reconstruction at diagnosis

• 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.

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 history of or concurrent malignancy of the ipsilateral or contralateral upper extremity- i.e. skin cancer

• Patients with history of lymphedema or lymphatic dysmotility of the ipsilateral or contralateral arm

• 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 history of allergy to ICG or Iodine/Shellfish

• Patients with evidence of liver dysfunction including diagnosis of end stage liver disease or abnormal liver tests at pre-op workup

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• ICG-guided manual lymphatic drainage
Participants will perform manual lymphatic drainage on their affected arm using ICG lymphography images of the lymphatic pathway in their affected arm as guidance once daily for 2 years post-surgery.
• Traditional manual lymphatic drainage
Participants will perform manual lymphatic drainage on their affected arm using traditional technique once daily for 2 years post-surgery.

Drug:
• Indocyanine green
All participants will be injected with indocyanine green for lymphatic mapping of the affected upper extremity, however this mapping will only be used to guide manual lymphatic drainage for participants on the ICG-guided manual lymphatic drainage arm.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject compliance	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.	2 years
Secondary	Relative volume change	Determine if patients undergoing ICG-guided MLD as compared to patients undergoing traditional MLD demonstrate reduced relative volume changes of the affected limb. The volume of the affected limb will be measured by circumferential limb measurements. These limb measurements will then be calculated into volume using conic geometry.	2 years
Secondary	Bioimpedance	Determine if patients undergoing ICG-guided MLD as compared to patients undergoing traditional MLD demonstrate lower rates of increased bioimpedance. Bioimpedance will be measured using both the sozo and in-body device methods.	2 years
Secondary	Breast cancer related lymphedema symptoms	Determine if patients undergoing ICG-guided MLD as compared to patients undergoing traditional MLD demonstrate lower rates of breast cancer related lymphedema symptoms. Breast cancer related lymphedema symptoms will be assessed by the Lymphedema Life Impact Scale questionnaire.	2 years
Secondary	Incidence of progression to late stage breast cancer related lymphedema	Compare the incidence of progression to late stage breast cancer related lymphedema in both arms	2 years
Secondary	Health-related quality of life	Compare health-related quality of life, as measured by the Lymphedema Life Impact Scale questionnaire, in both arms.	2 years