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

This study has been terminated.
Sponsor:
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01019512
First received: November 23, 2009
Last updated: March 23, 2010
Last verified: March 2010

November 23, 2009
March 23, 2010
July 2009
January 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Signs and symptoms of acute infection [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01019512 on ClinicalTrials.gov Archive Site
  • Weight [ Time Frame: At baseline and then monthly for 3 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: At baseline and then monthly for 3 months ] [ Designated as safety issue: No ]
  • Upper body function, based on the Disability of Arm, Shoulder, and Hand Scale (DASH) [ Time Frame: At baseline and then monthly for 3 months ] [ Designated as safety issue: No ]
  • Functional assessment, based on the Functional Assessment of Cancer Therapy Breast + 4 (FACT+4) [ Time Frame: At baseline and then monthly for 3 months ] [ Designated as safety issue: No ]
  • Quality of life, based on the Functional Assessment of Cancer Therapy Breast (FACT-B) [ Time Frame: At baseline and then monthly for 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Flexitouch Lymphedema System in Treating Stage II Lymphedema in Patients With Breast Cancer
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Lymphedema
  • Other: questionnaire administration
    Ancillary studies
  • Other: lymphedema management
  • 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.
    Interventions:
    • Other: questionnaire administration
    • 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.
    Interventions:
    • Other: questionnaire administration
    • Other: lymphedema management
  • Experimental: Arm III
    Patients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening.
    Interventions:
    • Other: questionnaire administration
    • Other: lymphedema management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
Not Provided
January 2011   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01019512
UPCC 02109, NCI-2009-01415
Yes
Alavi, Abass, Abramson Cancer Center of The University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Principal Investigator: Abass Alavi Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP