Flexitouch Lymphedema System in Treating Stage II Lymphedema in Patients With Breast Cancer

March 24, 2015 updated by: Abramson Cancer Center of the University of Pennsylvania

A Pilot, Randomized, Single-Blind Study to Assess the Efficacy of the Flexitouch® Lymphedema System in Reducing Lymphedema in Patients Treated for Breast Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVES: I. To quantitatively assess, by circumferential measurements and CT imaging techniques, the ability of the Flexitouch Lymphedema System to maintain reductions in limb volume after completion of the reductive phase of complex decongestive therapy in a population of patients with upper limb lymphedema secondary to the effects of breast cancer treatment. SECONDARY OBJECTIVES: I. To determine the drainage territory of the lymphatics of the affected arm and chest using CT and to determine whether these patterns are changed by treatment with the Flexitouch Lymphedema System/daytime garments versus Flexitouch Lymphedema System/daytime garments/nighttime bandaging versus standard self-care. OUTLINE: Patients are randomized to 1 of 3 treatment arms. Arm I: Patients undergo complex decongestive therapy comprising daily compression garment (sleeve and glove) use, daily manual lymphatic drainage (self-administered), and nighttime bandaging with low stretch Comprilan bandages. Arm II: 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. Arm III: Patients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening. In all arms, treatment continues for 3 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion

  • 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
  • Subjects must be capable of giving informed consent Exclusion
  • 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
  • Subjects cannot be homeless persons
  • Concomitant chemotherapy and radiation treatment during this study is not permitted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm I
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 administration
Ancillary studies
Other: lymphedema management
Experimental: Arm II
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 administration
Ancillary studies
Other: lymphedema management
Experimental: Arm III
Patients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening.
Other: questionnaire administration
Ancillary studies
Other: lymphedema management

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Upper extremity volume measured by circumferential measurements and by CT imaging
Time Frame: At baseline, monthly for 3 months (circumferential measurements only), and end of study
At baseline, monthly for 3 months (circumferential measurements only), and end of study
Signs and symptoms of acute infection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Weight
Time Frame: At baseline and then monthly for 3 months
At baseline and then monthly for 3 months
BMI
Time Frame: At baseline and then monthly for 3 months
At baseline and then monthly for 3 months
Upper body function, based on the Disability of Arm, Shoulder, and Hand Scale (DASH)
Time Frame: At baseline and then monthly for 3 months
At baseline and then monthly for 3 months
Functional assessment, based on the Functional Assessment of Cancer Therapy Breast + 4 (FACT+4)
Time Frame: At baseline and then monthly for 3 months
At baseline and then monthly for 3 months
Quality of life, based on the Functional Assessment of Cancer Therapy Breast (FACT-B)
Time Frame: At baseline and then monthly for 3 months
At baseline and then monthly for 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abramson Cancer Center of the University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abass Alavi, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPCC 02109
  • NCI-2009-01415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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