Back to results

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

Primary Purpose

Breast Cancer, Lymphedema

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

questionnaire administration

lymphedema management

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Abramson Cancer Center of The University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Upper extremity volume measured by circumferential measurements and by CT imaging

Signs and symptoms of acute infection

Secondary Outcome Measures

Weight

BMI

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

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

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

Full Information

NCT ID

NCT01019512

First Posted

November 23, 2009

Last Updated

March 24, 2015

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01019512

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Terminated

Study Start Date

July 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Lymphedema

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Active Comparator

Arm Description

Arm Title

Arm II

Arm Type

Experimental

Arm Description

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 Title

Arm III

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

lymphedema management

Primary Outcome Measure Information:

Title

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

Title

Signs and symptoms of acute infection

Secondary Outcome Measure Information:

Title

Weight

Time Frame