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Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer
This study is currently recruiting participants.
Verified by Vanderbilt University, September 2009
First Received: April 10, 2009   Last Updated: September 1, 2009   History of Changes
Sponsors and Collaborators: Vanderbilt University
Tactile Systems Technology Inc.
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00880022
  Purpose

No studies have tested the potential benefit of the Flexitouch® truncal/chest garments on reducing truncal lymphedema in breast cancer survivors (BCS) or the theoretical added benefit of applying truncal/chest pneumatic compression therapy to open lymph channels in individuals who have only limb lymphedema or its impact on the trunk/chest. The purpose of this two-part study is to fill gaps related to: 1) the impact of the Flexitouch® System on truncal lymphedema, and 2) the therapeutic benefit of truncal /chest pneumatic compression therapy for arm lymphedema.

Hypotheses:

Part One: BCS with arm and truncal lymphedema. H1: Arm swelling (as measured by bioelectrical impedance & arm girth in cm) will be reduced after 10 sessions with the Flexitouch® System. H2: Truncal swelling (as measured circumferentially) will be reduced after 10 sessions with the Flexitouch® System. H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by the Lymphedema Symptom Intensity and Distress Scale: Trunk and Arm) will be reduced after 10 sessions with the Flexitouch® System. H4: Functional assessment scores (as measured by the Functional Assessment Screening Questionnaire [FASQ] will improve after 10 sessions with the Flexitouch® System. Part Two: BCS with Arm Lymphedema H1: Arm volume (as measured by bioelectrical impedance & arm girth in cm) will be significantly reduced after one month of home use in participants using the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only). H2: Truncal measurements/volume (as measured circumferentially) will be less after one month of home use with the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only). H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by Lymphedema Symptom Intensity and Distress Scale - Arm ) will be significantly reduced after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only) . H4: Functional assessment scores (as measured by the FASQ) will be significantly higher after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only).


Condition Intervention Phase
Arm Lymphedema
Truncal Lymphedema
Breast Cancer
 Device: Flexitouch System
 Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome
MedlinePlus related topics: Breast Cancer Cancer Lymphedema
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Volume/circumferential reduction of lymphedema [ Time Frame: end of scheduled treaments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom improvement [ Time Frame: end of scheduled treatments ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
arm compression only: Active Comparator Device: Flexitouch System
pneumatic compression ( 10 to 30 treatments depending on group assignment)
arm, trunck and chest compression: Experimental Device: Flexitouch System
pneumatic compression ( 10 to 30 treatments depending on group assignment)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Individuals at least six months post- surgery and/or radiation treatment for breast cancer
  2. At least 21 years of age
  3. Lymphedema in one arm subsequent to breast cancer treatment with coexisting truncal swelling ** (Part One) and *lymphedema in one arm subsequent to breast cancer treatment without coexisting truncal swelling (Part Two)
  4. Willing and able to drive to the study site as needed
  5. Currently not using a compression pump or undergoing manual lymphatic drainage by a therapist

Exclusion Criteria:

  1. Actively undergoing or less than six months post intravenous chemotherapy or radiation therapy
  2. Individuals with congestive heart failure, chronic/acute renal disease, cor pulmonal, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, thrombophlebitis, deep vein thrombosis, infection of any kind and inflammation (redness) in the trunk or arms
  3. History of bilateral breast cancer
  4. Metastatic cancer
  5. Inability to stand upright
  6. Metal implants that would interfere with bioimpedance measurement equipment
  7. Pregnancy
  8. Pacemaker and internally implanted defibrillators
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880022

Contacts
Contact: Sheila h Ridner, Phd 615-322-0831 Sheila.Ridner@Vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt Univeristy Recruiting
Nashville, Tennessee, United States, 37240
Contact: Sheila H. Ridner, PhD     615-322-0831     Sheila.Ridner@Vanderbilt.edu    
Contact: Barbara Murphy, MD     615-343-4677     Barbara.Murphy@Vanderbilt.edu    
Principal Investigator: Sheila H Ridner, Phd            
Sponsors and Collaborators
Vanderbilt University
Tactile Systems Technology Inc.
Investigators
Principal Investigator: Sheila H Ridner, Phd Vanderbilt University School of Nursing
  More Information

No publications provided

Responsible Party: Vanderbilt University ( Sheila H. Ridner, Assistant Professor, PhD, RN )
Study ID Numbers: supp930
Study First Received: April 10, 2009
Last Updated: September 1, 2009
ClinicalTrials.gov Identifier: NCT00880022     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
compression
Flexitouch
breast cancer
lymphedema

Study placed in the following topic categories:
Lymphedema
Lymphatic Diseases
Skin Diseases
Breast Neoplasms
Breast Diseases

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

ClinicalTrials.gov processed this record on September 04, 2009



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