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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date March 16, 2020
Actual Study Start Date  ICMJE August 14, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer
Official Title  ICMJE Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy in Patients With Inflammatory Breast Cancer: A Prospective, Randomized Study
Brief Summary This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.
Detailed Description

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: Indocyanine Green
    Given IV
    Other Name: ICG
  • Procedure: Lymphangiography
    Undergo lymphangiography
    Other Name: Lymphography
  • Procedure: Lymphovenous Bypass
    Undergo LVB
    Other Name: Lymphovenous Anastomosis
Study Arms  ICMJE
  • Experimental: Group I (LVB)
    Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
    Interventions:
    • Drug: Indocyanine Green
    • Procedure: Lymphangiography
    • Procedure: Lymphovenous Bypass
  • No Intervention: Group II (no intervention)
    Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients willing to participate.
  • Patients able to complete informed consent.
  • Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy.

Exclusion Criteria:

  • Patients taking anticoagulants within 7 days prior to surgery.
  • Patients that are known to be pregnant at the time of surgery.
  • Patients are available for follow-up less than 18 months.
  • Patients with known iodine hypersensitivity.
  • Patients with known hypersensitivity to indocyanine green (ICG).
  • Patients with body mass index (BMI) greater than 40.0.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Schaverien 713-794-1247 mvschaverien@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941756
Other Study ID Numbers  ICMJE 2018-0127
NCI-2019-02320 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0127 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Mark Schaverien M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP