An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction
Primary Purpose
Breast Carcinoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mammoplasty
Vascularized Lymph Node Transfer
Sponsored by
About this trial
This is an interventional treatment trial for Breast Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients who have undergone treatment (mastectomy, axillary lymph node dissection [ALND], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction
Exclusion Criteria:
- Patients that are known to be pregnant at the time of surgery
- Patients with a known hypersensitivity to indocyanine green (ICG) and/or isosulfan blue (Lymphazurin)
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (vascularized lymph node transfer)
Arm Description
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
Outcomes
Primary Outcome Measures
Incidence rate of lymphedema development
Summary statistics such as means, standard deviations, median and range for continuous variables, and frequencies and percentages for categorical variables will be reported. The rate of lymphedema and its 95% exact confidence interval will be estimated.
Time to lymphedema development
Will be estimated by the Kaplan-Meier method.
Secondary Outcome Measures
Incidence rate of lymphedema development
The incidence of lymphedema between patients who undergo vascularized lymph node transfer (VLNT) and historical cohorts who do not will be compared. The inverse probability of treatment weighting using the propensity scores will be applied to estimate the effect of VLNT.
Complications of prophylactic VLNT
Overall complications will include infections, dehiscence, hematoma, seroma and flap compromises. The 95% exact confidence interval will be estimated.
Full Information
NCT ID
NCT03990610
First Posted
June 17, 2019
Last Updated
September 28, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03990610
Brief Title
An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction
Official Title
Assessment of Outcomes Following Prophylactic Lymph Node Transfer in Patients Undergoing Autologous Breast Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.
Detailed Description
PRIMARY OBJECTIVE:
I. Determine incidence of patients who develop lymphedema following autologous breast reconstruction.
SECONDARY OBJECTIVES:
I. Determine the overall complications of prophylactic vascularized lymph node transfers.
II. Compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer.
OUTLINE:
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
After completion of study, patients are followed up for 3 weeks, at 3 and 6 months, and then at 1 and 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (vascularized lymph node transfer)
Arm Type
Experimental
Arm Description
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
Intervention Type
Procedure
Intervention Name(s)
Mammoplasty
Other Intervention Name(s)
Breast Reconstruction
Intervention Description
Undergo standard of care breast reconstructive surgery
Intervention Type
Procedure
Intervention Name(s)
Vascularized Lymph Node Transfer
Other Intervention Name(s)
VLNT
Intervention Description
Undergo vascularized lymph node transfer
Primary Outcome Measure Information:
Title
Incidence rate of lymphedema development
Description
Summary statistics such as means, standard deviations, median and range for continuous variables, and frequencies and percentages for categorical variables will be reported. The rate of lymphedema and its 95% exact confidence interval will be estimated.
Time Frame
At 12 months after surgery
Title
Time to lymphedema development
Description
Will be estimated by the Kaplan-Meier method.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Incidence rate of lymphedema development
Description
The incidence of lymphedema between patients who undergo vascularized lymph node transfer (VLNT) and historical cohorts who do not will be compared. The inverse probability of treatment weighting using the propensity scores will be applied to estimate the effect of VLNT.
Time Frame
Up to 2 years
Title
Complications of prophylactic VLNT
Description
Overall complications will include infections, dehiscence, hematoma, seroma and flap compromises. The 95% exact confidence interval will be estimated.
Time Frame
Within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have undergone treatment (mastectomy, axillary lymph node dissection [ALND], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction
Exclusion Criteria:
Patients that are known to be pregnant at the time of surgery
Patients with a known hypersensitivity to indocyanine green (ICG) and/or isosulfan blue (Lymphazurin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward I Chang
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction
We'll reach out to this number within 24 hrs