N/A N=47 Randomized Treatment

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

Arm Lymphedema · Truncal Lymphedema · Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00880022 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Arm Volume at End of Study — 2376.52; 2539.93 ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Flexitouch System (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Vanderbilt University
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Arm Volume at End of Study	2376.52; 2539.93	—
SECONDARY Symptom Improvement	12.0; 15.0; 6.0; 10.0	—

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).

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00880022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.