Lymphedema Surveillance Study

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02743858
Collaborator
(none)
824
Enrollment
7
Locations
84
Anticipated Duration (Months)
117.7
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. The investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Bilateral arm measurements
  • Other: Body mass index (BMI)
  • Behavioral: Quality of Life Questionnaire

Study Design

Study Type:
Observational
Actual Enrollment :
824 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Surveillance Program for Assessment and Treatment of Breast Cancer-Related Lymphedema After Axillary Lymph Node Dissection
Actual Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Breast Cancer-Related Lymphedema

Bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) circumferential arm measurements with elastic tape taken at 4-cm intervals from the wrist to the shoulder and the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. Measurements will be performed at baseline (prior to surgery), post-operatively (after surgery) and at scheduled timepoints of 6 months, 12 months, 18 months, and 24 months after surgery for a total of 2 years. For a patient who is diagnosed with lymphedema at ≥ 13 months after surgery, surveillance will continue for an additional 12 months after [lymphedema] diagnosis, and total surveillance time may exceed 2 years. Height and weight will be obtained for each patient at baseline and at each scheduled visit for the purpose of calculating BMI. All patients will complete the ULL-27 (upper limb lymphedema) quality-of-life questionnaire at baseline and at each scheduled visit.

Other: Bilateral arm measurements
Will be obtained using the Perometer (Model 350 NT Perometer, Per-System) circumferential arm measurements with elastic tape taken at 4-cm intervals from the wrist to the shoulder, and the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. For patients who have not yet developed lymphedema by 2 years, an additional measurement at approximately 3 years post-surgery will be performed. If a patient is diagnosed with lymphedema at the 3-year visit, she will be asked to continue on study for an additional year.

Other: Body mass index (BMI)
Height and weight will be obtained for each patient at baseline and at each scheduled visit for the purpose of calculating BMI. BMI will be correlated with the presence of inflammatory biomarkers in the tissue, as well as with lymphedema development.

Behavioral: Quality of Life Questionnaire

Outcome Measures

Primary Outcome Measures

  1. number of incidences of lymphedema [2 year]

    as defined by perometry using rigorous measurement protocols. Bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) and the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Female breast cancer patients over the age of 18

  • Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if <6 months from consent)

  • Patients consenting for unilateral sentinel lymph node biopsy (SLNB) and possible ALND are eligible for initial entry into the study, but will become ineligible if ALND is not performed

Exclusion Criteria:
  • Male breast cancer patients

  • Patients treated with SLNB only

  • Patients consenting for bilateral axillary surgery

  • Patients with prior history of surgical excision of one or more axillary lymph nodes or SLNB, performed >6 months from date of consent

  • Patients with prior history of ALND

  • Patients with no breast surgery performed at MSK

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Memorial Sloan Kettering Basking Ridge (Consent only)Basking RidgeNew JerseyUnited States07920
2Memorial Sloan Kettering Monmouth (Consent only)MiddletownNew JerseyUnited States07748
3Memorial Sloan Kettering Bergen (Consent only)MontvaleNew JerseyUnited States07645
4Memorial Sloan Kettering Commack (Consent only)CommackNew YorkUnited States11725
5Memorial Sloan Kettering Westchester (Consent only)HarrisonNew YorkUnited States10604
6Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
7Memorial Sloan Kettering Nassau (Consent only)UniondaleNew YorkUnited States11553

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Andrea Barrio, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02743858
Other Study ID Numbers:
  • 16-220
First Posted:
Apr 19, 2016
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021