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Lymphedema Surveillance Study

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ClinicalTrials.gov Identifier: NCT02743858
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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 disease Intervention/treatment
Breast Cancer Lymphedema Other: Bilateral arm measurements Other: Body mass index (BMI) Behavioral: Quality of Life Questionnaire

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Study Type : Observational
Estimated Enrollment : 700 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 : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Group/Cohort Intervention/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.

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



Primary Outcome Measures :
  1. number of incidences of lymphedema [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
breast tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MSK clinics
Criteria

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

Information from the National Library of Medicine

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): NCT02743858


Contacts
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Contact: Andrea Barrio, MD 646-888-5117
Contact: Babak Mehrara, MD 212-639-8639

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andrea Barrio, MD    646-888-5117      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Andrea Barrio, MD    646-888-5117      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Andrea Barrio, MD    646-888-5117      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Andrea Barrio, MD    646-888-5117      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrea Barrio, MD    646-888-5117      
Contact: Babak Mehrara, MD    212-639-8639      
Principal Investigator: Andrea Barrio, MD         
Memorial Sloan Kettering Rockville Recruiting
Rockville Centre, New York, United States, 11570
Contact: Andrea Barrio, MD    646-888-5117      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Andrea Barrio, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02743858     History of Changes
Other Study ID Numbers: 16-220
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
Lymphedema
Surveillance Program
Axillary Lymph Node Dissection
16-220

Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes