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

NCT ID: NCT01019512

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31

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.

Conditions

Breast Cancer; Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

questionnaire administration

Intervention Type: OTHER

Ancillary studies

lymphedema management

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

questionnaire administration

Intervention Type: OTHER

Ancillary studies

lymphedema management

Intervention Type: OTHER

Arm III

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

Group Type: EXPERIMENTAL

questionnaire administration

Intervention Type: OTHER

Ancillary studies

lymphedema management

Intervention Type: OTHER

Interventions

questionnaire administration

Ancillary studies

Intervention Type: OTHER

lymphedema management

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Abramson Cancer Center of The University of Pennsylvania

Principal Investigators

Abass Alavi

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2009-01415

Identifier Type: -

Identifier Source: secondary_id

UPCC 02109

Identifier Type: -

Identifier Source: org_study_id