Lymphedema Surveillance Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Initially consented patients, treated with SLNB alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment
Disqualifiers
Male breast cancer patients
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
Trial design
Treatments tested in this trial
- Bilateral arm measurements
- Body mass index (BMI)
- Quality of Life Questionnaire
- Blood draw
Treatment groups
1,250 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov