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

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ClinicalTrials.gov Identifier: NCT03648983
Recruitment Status : Terminated (Pi departure; service discontinued study)
First Posted : August 28, 2018
Results First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Albert Einstein College of Medicine

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.

Condition or disease Intervention/treatment Phase
Lymphedema Breast Cancer Procedure: arm circumference measurement Device: Bioimpedance spectroscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Randomized Trial Comparing Arm Circumference and Bioimpedance Measurement for Early Detection and Treatment of Lymphedema in Patients Undergoing Axillary Lymph Node Dissection or Sentinel Node Biopsy
Study Start Date : November 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Active Comparator: Standard LE detection
Arm measurements taken. Patients undergo arm circumference measurement at 4, 10, 16, 22, 28, and 34 months.
Procedure: arm circumference measurement
Undergo arm circumference measurement

Experimental: 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.
Procedure: arm circumference measurement
Undergo arm circumference measurement

Device: Bioimpedance spectroscopy
bioimpedance spectroscopy
Other Name: BIS




Primary Outcome Measures :
  1. Rates of Enhanced Lymphedema Detection [ Time Frame: During treatment (Up to 34 months) ]

    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.***



Secondary Outcome Measures :
  1. Severity of Enhanced Lymphedema [ Time Frame: During treatment (Up to 34 months) ]
    Severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, 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.

  2. Percentage of Subjects With Complete Resolution of Signs of Enhanced Lymphedema [ Time Frame: During treatment (up to 34 months) plus 1 year post treatment ]
    The Fisher's exact test will be used to compare between the enhanced vs. standard detection groups the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment. Logistic regression models will also be fit to the data to adjust for potential confounders.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648983


Locations
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United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lisa Wiechmann Albert Einstein College of Medicine

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Responsible Party: Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03648983     History of Changes
Other Study ID Numbers: 11-06-235
NCI-2014-01480 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
11-06-235E ( Other Identifier: Albert Einstein College of Medicine )
11-047 ( Other Identifier: Albert Einstein College of Medicine )
LDEX ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2018    Key Record Dates
Results First Posted: October 1, 2018
Last Update Posted: October 1, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Albert Einstein College of Medicine:
Enhanced Lymphedema
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases