Arm Circumference Measurement With or Without Bioimpedance Spectroscopy in Finding Lymphedema Early in Patients With Stage I-III Breast Cancer

Stopped early · Not applicable

Conditions studied: Lymphedema, Breast Cancer

In brief

This randomized pilot clinical trial studies arm circumference measurement with or without bioimpedance spectroscopy in finding extra lymph node fluid build up in the arm (lymphedema) early in patients with stage I-III breast cancer undergoing lymph node dissection or sentinel node biopsy. Diagnostic procedures, such as bioimpedance spectroscopy, may allow doctors to find and diagnose lymphedema earlier than arm circumference measurement alone.

Key facts

Study ID

NCT03648983

Run by

Albert Einstein College of Medicine

People needed

95

Starts

2011-11-01

Expected to finish

2015-08-01

Last updated by the study team

2018-10-01

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed with stage I-III cancer of the female breast
• Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy as well as before surgery
• Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy as well as before surgery
• Patients with a history of other invasive malignancies are eligible as long as they have no evidence of disease 5 years post-diagnosis
• Patients with basal cell and squamous cell cancer of the skin are eligible
• Patients willing to return to the study site for the duration of the study (34 months)

You may not qualify if…

• Pregnant women
• Patients who are homebound or dependent upon a walker or wheelchair for mobility
• Patients diagnosed enhanced lymphedema
• Hypertensive patients who are using diuretics
• Documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
• Prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer

Where it is running

• Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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