NCT01019512

Brief Summary

RATIONALE: The Flexitouch lymphedema system may lessen lymphedema caused by treatment for breast cancer. It is not yet known whether the Flexitouch lymphedema system is more effective than complex decongestive therapy in treating lymphedema. PURPOSE: This randomized clinical trial is studying the Flexitouch lymphedema system in treating stage II lymphedema in patients with breast cancer.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

1.5 years

First QC Date

November 23, 2009

Last Update Submit

March 24, 2015

Conditions

Breast CancerLymphedema

Outcome Measures

Primary Outcomes (2)

  • Upper extremity volume measured by circumferential measurements and by CT imaging

    At baseline, monthly for 3 months (circumferential measurements only), and end of study

  • Signs and symptoms of acute infection

Secondary Outcomes (5)

  • Weight

    At baseline and then monthly for 3 months

  • BMI

    At baseline and then monthly for 3 months

  • Upper body function, based on the Disability of Arm, Shoulder, and Hand Scale (DASH)

    At baseline and then monthly for 3 months

  • Functional assessment, based on the Functional Assessment of Cancer Therapy Breast + 4 (FACT+4)

    At baseline and then monthly for 3 months

  • Quality of life, based on the Functional Assessment of Cancer Therapy Breast (FACT-B)

    At baseline and then monthly for 3 months

Study Arms (3)

Arm I

ACTIVE COMPARATOR

Patients undergo complex decongestive therapy comprising daily compression garment (sleeve and glove) use, daily manual lymphatic drainage (self-administerd), and nighttime bandaging with low stretch Comprilan bandages.

Other: questionnaire administrationOther: lymphedema management

Arm II

EXPERIMENTAL

Patients undergo daily compression with garments (sleeve and glove), nighttime bandaging with low stretch Comprilan bandages, and daily Flexitouch treatment over 1 hour every evening.

Other: questionnaire administrationOther: lymphedema management

Arm III

EXPERIMENTAL

Patients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening.

Other: questionnaire administrationOther: lymphedema management

Interventions

questionnaire administrationOTHER

Ancillary studies

Arm IArm IIArm III
lymphedema managementOTHER
Arm IArm IIArm III

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have a known, clinical diagnosis of stage II lymphedema as verified by a physician specializing in this disorder
  • Subjects must have had a unilateral mastectomy, lymph node (LN) dissection and/or radiation therapy for the treatment of primary breast cancer
  • Subjects must have completed their course of adjuvant chemotherapy
  • Clinical assessment of lymphedema demonstrating at least 10% difference between the volumes of the affected and opposite limbs at the time of enrollment
  • Subjects must be completing phase I of their CDT for their initial onset of lymphedema or for an acute flare of lymphedema
  • History of prior trauma and/or surgery in the affected limb other than that for treatment of breast cancer
  • Patients with recurrent breast cancer
  • History of bilateral breast cancer
  • Subjects currently receiving other therapies for lymphedema
  • Subjects with renal, liver, and/or heart dysfunction
  • Open wounds or web syndrome
  • Active/acute infection (cellulitis)
  • Acute DVT/Thrombophlebitis
  • Decompensated or untreated congestive heart failure
  • Pulmonary embolism - Pregnancy as confirmed by urine test; all patients of child bearing potential will be required to have a urine pregnancy test
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

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

Study Officials

  • Abass Alavi

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 24, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2011

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

US(1)