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Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Tactile Systems Technology Inc.
Information provided by (Responsible Party):
Sheila H. Ridner, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00880022
First received: April 10, 2009
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Arm Volume at End of Study [ Time Frame: end of scheduled treatments-day 30 of treatment ] [ Designated as safety issue: No ]
    measured by tape and then volume was calculated.


Secondary Outcome Measures:
  • Symptom Improvement [ Time Frame: end of scheduled treatments-day 30 of treatment ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: May 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: arm compression only Device: Flexitouch System
pneumatic compression ( 10 to 30 treatments depending on group assignment)
Experimental: arm, trunk and chest compression 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

Locations
United States, Tennessee
Vanderbilt Univeristy
Nashville, Tennessee, United States, 37240
Sponsors and Collaborators
Vanderbilt University
Tactile Systems Technology Inc.
Investigators
Principal Investigator: Sheila H Ridner, Phd Vanderbilt University School of Nursing
  More Information

Publications:

Responsible Party: Sheila H. Ridner, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00880022     History of Changes
Obsolete Identifiers: NCT01097291
Other Study ID Numbers: supp930
Study First Received: April 10, 2009
Results First Received: August 14, 2012
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
compression
Flexitouch
breast cancer
lymphedema

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

ClinicalTrials.gov processed this record on May 23, 2013