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| ID | Type | Description | Link |
|---|---|---|---|
| IRB202400626 | Other Identifier | University of Florida | |
| OCR44989 | Other Identifier | University of Florida |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG-guided manual lymphatic drainage | Experimental |
| |
| Traditional manual lymphatic drainage | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG-guided manual lymphatic drainage | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Portillo | Contact | 352-273-3650 | portillos@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Spiguel, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
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| Traditional manual lymphatic drainage | Procedure | Participants will perform manual lymphatic drainage on their affected arm using traditional technique once daily for 2 years post-surgery. |
|
| Indocyanine green | Drug | 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. |
|
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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