Breast Cancer Clinical Trial

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

Summary

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.

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Full Description

PRIMARY OBJECTIVES:

I. To test, in a randomized controlled trial, the ability of the enhanced lymphedema (LE) detection program (ELED) versus arm circumference alone to detect early/reversible LE.

II. To compare the severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, between the two detection modalities.

III. To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement/bioimpedance spectroscopy (BIS) difference.

IV. To compare the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment between the enhanced vs. standard detection groups.

V. To determine compliance with LE preventive care and treatment.

Patients are randomized to 1 of 2 arms: those undergo arm circumference measurement only and those undergoing undergo arm circumference measurement and bioimpedance spectroscopy. Measurements taken at 4, 10, 16, 22, 28, and 34 months.

In both arms, if lymphedema is diagnosed, patients are given a compression garment to wear daily for 6 weeks. If lymphedema does not improve after 6 weeks, patients undergo complete decongestive therapy over approximately 1 hour three times a week. Patients complete remedial exercises comprising active, repetitive range of motion of the involved extremity and light aerobic conditioning until extremity volume stabilizes or improves. Patients are also instructed to perform exercises at home.

After completion of study, patients diagnosed with lymphedema are followed up for 1 year.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

95

Study ID:

NCT03648983

Recruitment Status:

Terminated

Sponsor:

Albert Einstein College of Medicine

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There is 1 Location for this study

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Albert Einstein College of Medicine
Bronx New York, 10461, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

95

Study ID:

NCT03648983

Recruitment Status:

Terminated

Sponsor:


Albert Einstein College of Medicine

How clear is this clinincal trial information?

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