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

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.

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