NCT00880022

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 13, 2012

Completed
Last Updated

December 5, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

April 10, 2009

Results QC Date

August 14, 2012

Last Update Submit

November 1, 2017

Conditions

Arm LymphedemaTruncal LymphedemaBreast Cancer

Keywords

compressionFlexitouchbreast cancerlymphedema

Outcome Measures

Primary Outcomes (1)

  • Arm Volume at End of Study

    measured by tape and then volume was calculated.

    end of scheduled treatments-day 30 of treatment

Secondary Outcomes (1)

  • Symptom Improvement

    Before first treatment and end of all treatments

Study Arms (2)

arm compression only

ACTIVE COMPARATOR

Intervention of arm compression only by Flexitouch System

Device: Flexitouch System

arm, trunk and chest compression

EXPERIMENTAL

Intervention of arm, trunk and chest compression by Flexitouch System

Device: Flexitouch System

Interventions

Flexitouch SystemDEVICE

( 10 to 30 treatments depending on group assignment)

arm compression onlyarm, trunk and chest compression

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals at least six months post- surgery and/or radiation treatment for breast cancer
  • At least 21 years of age
  • 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)
  • Willing and able to drive to the study site as needed
  • Currently not using a compression pump or undergoing manual lymphatic drainage by a therapist

You may not qualify if:

  • Actively undergoing or less than six months post intravenous chemotherapy or radiation therapy
  • 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
  • History of bilateral breast cancer
  • Metastatic cancer
  • Inability to stand upright
  • Metal implants that would interfere with bioimpedance measurement equipment
  • Pregnancy
  • Pacemaker and internally implanted defibrillators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Univeristy

Nashville, Tennessee, 37240, United States

Location

Related Publications (2)

  • Ridner SH, Murphy B, Deng J, Kidd N, Galford E, Dietrich MS. Advanced pneumatic therapy in self-care of chronic lymphedema of the trunk. Lymphat Res Biol. 2010 Dec;8(4):209-15. doi: 10.1089/lrb.2010.0010.

    PMID: 21190493RESULT

  • Ridner SH, Murphy B, Deng J, Kidd N, Galford E, Bonner C, Bond SM, Dietrich MS. A randomized clinical trial comparing advanced pneumatic truncal, chest, and arm treatment to arm treatment only in self-care of arm lymphedema. Breast Cancer Res Treat. 2012 Jan;131(1):147-58. doi: 10.1007/s10549-011-1795-5. Epub 2011 Sep 30.

    PMID: 21960113RESULT

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
sheila h ridner
Organization
vanderbilt university
Sheila.Ridner@Vanderbilt.edu
615-322-0831

Study Officials

  • Sheila H Ridner, Phd

    Vanderbilt University School of Nursing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

December 5, 2017

Results First Posted

September 13, 2012

Record last verified: 2017-11

Locations

US(1)