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

Not Applicable

Terminated

• Conditions: Breast Cancer; Lymphedema
• Interventions: Other: questionnaire administration; Other: lymphedema management

• Registration Number: NCT01019512
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Study First Posted: 2009-11-24
• Primary Completion: 2011-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	questionnaire administration	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.
Arm I	lymphedema management	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.
Arm II	questionnaire administration	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 II	lymphedema management	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	questionnaire administration	Patients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening.
Arm III	lymphedema management	Patients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Abramson Cancer Center of The University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States