A Pilot, Randomized, Single-Blind Study to Assess the Efficacy of the Flexitouch® Lymphedema System in Reducing Lymphedema in Patients Treated for Breast Cancer
N/A
N/A
Female
Breast Cancer, Lymphedema
Trial Information
A Pilot, Randomized, Single-Blind Study to Assess the Efficacy of the Flexitouch® Lymphedema System in Reducing Lymphedema in Patients Treated for Breast Cancer
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Upper extremity volume measured by circumferential measurements and by CT imaging
Outcome Time Frame:
At baseline, monthly for 3 months (circumferential measurements only), and end of study
Safety Issue:
No
Principal Investigator
Abass Alavi
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Institutional Review Board
Study ID:
UPCC 02109
NCT ID:
NCT01019512
Start Date:
July 2009
Completion Date:
Related Keywords:
- Breast Cancer
- Lymphedema
- Breast Neoplasms
- Lymphedema
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
