Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by ImpediMed Limited
Sponsor:
Collaborators:
Vanderbilt University
Macquarie University, Australia
Massey Cancer Center
Summa Health System
Information provided by (Responsible Party):
ImpediMed Limited
ClinicalTrials.gov Identifier:
NCT02167659
First received: June 12, 2014
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

Based upon the current state of science, the investigators are proposing to conduct a randomized clinical trial in which participants are randomized post-surgery to either BIS or circumferential (tape) measurements for follow-up arm measurements. When patients in the BIS group have an L-Dex change that is ≥10 units higher than the pre-surgical baseline measure, and when patients in the tape measurement group have a volume change in the at-risk arm that is ≥ 10% above pre-surgical baselines (without similar change in non-at-risk arm), both will receive four weeks of 20-30 mm compression sleeve and gauntlet therapy.


Condition Intervention
Lymphedema
Device: 20-30 mmHg compression sleeve with gauntlet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement in the Prevention of Lymphedema Following Locoregional Treatment for Breast Cancer

Resource links provided by NLM:


Further study details as provided by ImpediMed Limited:

Primary Outcome Measures:
  • Rate of progression of lymphedema [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To determine if subclinical detection of extracellular fluid accumulation via bioimpedance spectroscopy and subsequent early intervention reduce the rate of progression to CDP relative to rates seen using standard tape measurements.


Secondary Outcome Measures:
  • Number of participants with risk factors associated with lymphedema. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To evaluate factors associated with progression requiring CDP (e.g., Body Mass Index (BMI), Seroma, Smoking, Age, Air Travel).

  • Time elapsed between identification of increasing fluid and referral out of study for continued swelling. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To evaluate time to progression requiring CDP.

  • Number of participants with improved skin condition, symptoms and quality of life. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    To determine if subclinical detection of extracellular fluid accumulation and subsequent early intervention improves skin condition, symptoms, and quality of life compared with standard tape measurements


Estimated Enrollment: 1100
Study Start Date: June 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIS Assessment
Patients will undergo measurements by trained staff. Follow-up visits will be performed at 3, 6, 12, 18, 24, and 36 months. Visits will include L-Dex, skin assessment and self-report forms (LSIDS-A and FACTB Plus 4). Patients that have no change of greater than or equal to 10 units will continue follow-up for 36 months. Patients with an L-Dex value change greater than or equal to 10 will undergo circumference measurement and begin treatment with a 20-30 mmHg compression sleeve with gauntlet for 4 weeks. At the end of 4 weeks patients will have their arms measured. Those demonstrating improvement will continue with follow up. Those not demonstrating improvement will be removed from the study and their medical oncologist or surgeon will be notified as CDP will be needed.
Device: 20-30 mmHg compression sleeve with gauntlet
A compression intervention consisting of a sleeve and gauntlet with 20-30mm of tension worn for four weeks that is initiated based on a BIS L-Dex change that is ≥10 units higher than pre-surgical baseline measure, or a tape measurement guided volume change in the affected arm that is ≥ 10% above pre-surgical baseline.
Active Comparator: Tape Measure
Patients will undergo measurements by trained staff. Follow-up visits will be performed at 3, 6, 12, 18, 24, and 36 months. Visits will include volume assessment using tape measure, skin assessment and self-report forms (LSIDS-A and FACTB Plus 4). Patients that have no volume increase will continue follow-up for 36 months. Patients with a volume change of greater than or equal to 10% in the at-risk limb will undergo L-Dex measurement and begin treatment with a 20-30 mmHg compression sleeve with gauntlet for 4 weeks. At the end of 4 weeks patients will have their arms measured. Those demonstrating improvement will continue with follow up. Those not demonstrating improvement will be removed from the study and their medical oncologist or surgeon will be notified as CDP will be needed.
Device: 20-30 mmHg compression sleeve with gauntlet
A compression intervention consisting of a sleeve and gauntlet with 20-30mm of tension worn for four weeks that is initiated based on a BIS L-Dex change that is ≥10 units higher than pre-surgical baseline measure, or a tape measurement guided volume change in the affected arm that is ≥ 10% above pre-surgical baseline.

Detailed Description:

The treatment of lymphedema following breast cancer therapy is typically a burdensome multi-modality process that entails different degrees of intensity depending on the severity of fluid accumulation. In breast cancer survivors, it is most commonly initiated after visible swelling occurs in a limb. Common treatments utilized are multi-modality and include massage, compression, exercises, and skin care. The current gold standard treatment for advanced fluid accumulation is complex decongestive physiotherapy (CDP). CDP includes components of compression, lymphatic drainage, skin care, and exercise and is commonly delivered in two phases with the first phase being a several week course delivered in the outpatient clinical setting and the second a home maintenance program. CDP is considered the gold standard due to prospective data demonstrating its efficacy, a series of 537 patients found significant arm volume decreases with CDP and subsequent studies have confirmed volume reductions along with improved quality of life in those patients undergoing CDP. Studies comparing CDP to other treatment modalities are limited but some have favored CDP. CDP is limited in that access to long term prospective follow-up treatment may not take place and it requires significant resources and costs.

Recent studies have suggested that early diagnosis and treatment allow for less burdensome and aggressive therapy utilization moving forward. Increasing data support the idea that early intervention improves outcomes for women with lymphedema following breast cancer treatment. Recent prospective data have shown that with a short course of compression therapy (sleeve and gauntlet), ranging from 4 to 6 weeks, the rate of progression of fluid accumulation is limited. Specifically, the Stout Gergich et al. study provided sound preliminary data to support that four weeks of treatment using a 20-30 mmHg compression garment and gauntlet can, over 18 months of post intervention follow-up, reduce volume and prevent the need for CDP.

These findings are encouraging; however, it should be noted that these studies have significant limitations including small patient numbers, limited follow up, a lack of randomization, and a lack of subclinical detection of increasing extracellular fluid. Therefore, while some data exist that suggest that early intervention with clinically apparent extracellular fluid accumulation is beneficial, there are less data to support the hypothesis that subclinical detection and subsequent early intervention are beneficial. Based on data from these studies, it may be possible to prevent chronic lymphedema with early detection and intervention. Early detection may be best achieved by identifying changes in extracellular fluid instead of change in whole arm volume. Given the potential to improve patient outcomes and possibly prevent chronic lymphedema, additional research is warranted in large randomized trials that address some of the limitations of the previous work.

BIS is a technology designed to identify changes in extracellular fluid. The investigators propose to determine if subclinical detection of increasing extracellular fluid via BIS and subsequent early treatment with four weeks of a compression sleeve and gauntlet results in a reduction in the rates of progression to chronic lymphedema as compared to the same intervention when initiated from use of the most common arm measurement method (tape measurement).

The investigators will secondarily explore selective correlatives related to lymphedema and lymphedema progression. As multiple factors may lead to lymphedema, the influence of potential risk factors on lymphedema progression will be evaluated. Time to actual progression will also be examined. Because lymphedema results in problematic symptoms and diminished quality of life, correlatives using validated instruments will also be examined.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed invasive breast cancer or Ductal Carcinoma In Situ (DCIS)
  • Planned surgical procedure
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Prior history of breast cancer, breast/chest wall/axillary radiation therapy
  • Definitive breast surgical procedure prior to enrollment.
  • Active implanted medical device (e.g., cardiac pacemakers, defibrillators) or patients connected to electronic life support devices or metallic devices that would interfere with BIS measurements.
  • Conditions that could cause swelling (e.g., pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis, or deep vein thrombosis in arms
  • Previous treatment for lymphedema of either arm.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or cardiac arrhythmia.
  • Psychiatric illness (e.g., diagnosed schizophrenia or documented dementia) that would limit compliance with study requirements.
  • Known allergy to electrode adhesives or woven knit compression fabrics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02167659

Contacts
Contact: Sheila H Ridner, PhD 615-322-0831 sheila.ridner@Vanderbilt.Edu
Contact: Vandana Abramson, MD Vandana.Abramson@Vanderbilt.edu

Locations
United States, Ohio
Summa Health System Not yet recruiting
Akron, Ohio, United States, 44304
Contact: Chirag Shah, MD    248-217-7810    shahc@summahealth.org   
Principal Investigator: Chirag Shah, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37240
Contact: Sheila H Ridner, PhD    615-322-0831    Sheila.Ridner@Vanderbilt.Edu   
Contact: Vandana Abramson, MD    615-322-2064    Vandana.Abramson@Vanderbilt.Edu   
Principal Investigator: Sheila Ridner, PhD         
United States, Virginia
Massey Cancer Center Not yet recruiting
Richmond, Virginia, United States, 23298
Contact: Douglas Arthur, MD    804-828-7232    DArthur@mcvh-vcu.edu   
Principal Investigator: Douglas Arthur, MD         
Australia, New South Wales
Macquarie University Not yet recruiting
Sydney, New South Wales, Australia, 2109
Contact: John Boyages, PhD    +61 2 9812 3508    john.boyages@mq.edu.au   
Contact: Louise Koelmeyer, BAppSc    +61 2 9812 3501    Louise.Koelmeyer@mq.edu.au   
Principal Investigator: John Boyages, PhD         
Principal Investigator: Louise Koelmeyer, BAppSc         
Sponsors and Collaborators
ImpediMed Limited
Vanderbilt University
Macquarie University, Australia
Massey Cancer Center
Summa Health System
Investigators
Principal Investigator: Sheila H Ridner, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: ImpediMed Limited
ClinicalTrials.gov Identifier: NCT02167659     History of Changes
Other Study ID Numbers: VICCBRE1438
Study First Received: June 12, 2014
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by ImpediMed Limited:
Lymphedema
Breast cancer
Bioimpedance Spectroscopy
L-Dex

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014