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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-05172 | Other Identifier | National Cancer Institute: Clinical Trials Reporting Program |
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Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema.
Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Group A will under axillary lymphadenectomy alone |
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| Group B | Active Comparator | Group B will undergo axillary lymphadenectomy with soft tissue reinforcement(STR) |
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| Group C | Experimental | Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) | Procedure | lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphatic flow pattern of whole limb | In the early lymphedema stages this exam allows to detect percutaneously the lymphatic vessels of the whole limb, up to about 1 cm in depth from the skin surface, by an infrared camera visualization system after intra-dermal injection of ICG in the hand. The change in the lymphatic pattern and reduction in the ICG velocity will be tested to find a correlation with other used diagnostic parameters like volume change and bioimpedance spectroscopy. | 2 yr |
| Limb Volume | Limb volume as measured by serial assessment | 2 yr |
| Skin thickness measurements | Skin thickness is changed by lymphedema | 2 yr |
| Bioiimpedance spectroscopy | Impedance of the skin changes with lymphedema | 2 yr |
| Quality of life- Limb-Lymphedema-Specific Quality of Life (LYMQOL) | Questionnaire to determine patient reported quality of life. Measured by limb-lymphedema-specific quality of life (LYMQOL) tool. The LYMQOL is divided into four domains: Function, Appearance, Symptoms, and Mood, as well as yielding an overall quality-of-life score | 2 yr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dung Nguyen, MD, PharmD | Contact | 6504929239 | nguyendh@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dung Nguyen, MD, PharmD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Recruiting | San Francisco | California | 94305 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2024 | Sep 4, 2025 |
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| Axillary lymphadenetomy alone | Procedure | oncologic axillary lymphadenectomy |
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| axillary lymphadenectomy with soft tissue reinforcement | Procedure | axillary lymphadenectomy with soft tissue reinforcement(STR) |
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| Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2021 | Jun 16, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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