Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03941756|
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : March 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Inflammatory Breast Carcinoma Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8||Drug: Indocyanine Green Procedure: Lymphangiography Procedure: Lymphovenous Bypass||Early Phase 1|
I. To evaluate the protective benefit to performing lymphovenous bypass (LVB) surgery at the time of axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.
I. Compare the medical outcomes for patients receiving LVB surgery with those receiving standard surgery without the intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND.
GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy in Patients With Inflammatory Breast Cancer: A Prospective, Randomized Study|
|Actual Study Start Date :||August 14, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Group I (LVB)
Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
Drug: Indocyanine Green
Other Name: ICG
Other Name: Lymphography
Procedure: Lymphovenous Bypass
Other Name: Lymphovenous Anastomosis
No Intervention: Group II (no intervention)
Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
- Volumetric diagnosis of lymphedema [ Time Frame: 18 months ]If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.
- Incidence of lymphedema [ Time Frame: 18 months ]Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941756
|Contact: Mark Schaverienfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Mark Schaverien 713-794-1247|
|Principal Investigator: Mark Schaverien|
|Principal Investigator:||Mark Schaverien||M.D. Anderson Cancer Center|