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

NCT ID: NCT03648983

Last Updated: 2018-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-08-31

Brief 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.

Detailed 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.

Conditions

Lymphedema; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard LE detection

Arm measurements taken. Patients undergo arm circumference measurement at 4, 10, 16, 22, 28, and 34 months.

Group Type: ACTIVE_COMPARATOR

arm circumference measurement

Intervention Type: PROCEDURE

Undergo arm circumference measurement

Enhanced LE detection

Bioimpedance spectroscopy used along with arm measurements. Patients undergo arm circumference measurement and bioimpedance spectroscopy at 4, 10, 16, 22, 28, and 34 months.

Group Type: EXPERIMENTAL

arm circumference measurement

Intervention Type: PROCEDURE

Undergo arm circumference measurement

Bioimpedance spectroscopy

Intervention Type: DEVICE

bioimpedance spectroscopy

Interventions

arm circumference measurement

Undergo arm circumference measurement

Intervention Type: PROCEDURE

Bioimpedance spectroscopy

bioimpedance spectroscopy

Intervention Type: DEVICE

Other Intervention Names

BIS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Wiechmann

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

Other Identifiers

NCI-2014-01480

Identifier Type: REGISTRY

Identifier Source: secondary_id

11-06-235E

Identifier Type: OTHER

Identifier Source: secondary_id

11-047

Identifier Type: OTHER

Identifier Source: secondary_id

LDEX

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA013330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-06-235

Identifier Type: -

Identifier Source: org_study_id