Breast Carcinoma
Conditions
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.
Interventions
PROCEDUREMammoplasty
Undergo standard of care breast reconstructive surgery
PROCEDUREVascularized Lymph Node Transfer
Undergo vascularized lymph node transfer
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of lymphedema development | At 12 months after surgery | 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 | Up to 2 years | Will be estimated by the Kaplan-Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of lymphedema development | Up to 2 years | 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 | Within 30 days after surgery | Overall complications will include infections, dehiscence, hematoma, seroma and flap compromises. The 95% exact confidence interval will be estimated. |
Countries
United States
Outcome results
None listed