NCT03648983

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
1 month until next milestone

Results Posted

Study results publicly available

October 1, 2018

Completed
Last Updated

October 1, 2018

Status Verified

August 1, 2018

Enrollment Period

3.8 years

First QC Date

October 8, 2015

Results QC Date

August 31, 2018

Last Update Submit

August 31, 2018

Conditions

LymphedemaBreast Cancer

Keywords

Enhanced Lymphedema

Outcome Measures

Primary Outcomes (1)

  • Rates of Enhanced Lymphedema Detection

    Rates of enhanced lymphedema detection will be compared between the enhanced versus standard detection groups with the Fisher's exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models. \*\*\* Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.\*\*\*

    During treatment (Up to 34 months)

Secondary Outcomes (2)

  • Severity of Enhanced Lymphedema

    During treatment (Up to 34 months)

  • Percentage of Subjects With Complete Resolution of Signs of Enhanced Lymphedema

    During treatment (up to 34 months) plus 1 year post treatment

Study Arms (2)

Standard LE detection

ACTIVE COMPARATOR

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

Procedure: arm circumference measurement

Enhanced LE detection

EXPERIMENTAL

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

Procedure: arm circumference measurementDevice: Bioimpedance spectroscopy

Interventions

arm circumference measurementPROCEDURE

Undergo arm circumference measurement

Enhanced LE detectionStandard LE detection
Bioimpedance spectroscopyDEVICE

bioimpedance spectroscopy

Also known as: BIS
Enhanced LE detection

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Lisa Wiechmann
Organization
Montefiore Medical Center
lwiechma@montefiore.org

Study Officials

  • Lisa Wiechmann

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

August 28, 2018

Study Start

November 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 1, 2018

Results First Posted

October 1, 2018

Record last verified: 2018-08

Locations

US(1)