Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
Lymphedema
 Other: questionnaire administration
Other: lymphedema management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot, Randomized, Single-Blind Study to Assess the Efficacy of the Flexitouch® Lymphedema System in Reducing Lymphedema in Patients Treated for Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Other: questionnaire administration
Ancillary studies
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.
 Other: questionnaire administration
Ancillary studies
Other: lymphedema management
Experimental: Arm III
Patients undergo daily compression with garments (sleeve and glove) and daily Flexitouch treatment over 1 hour every evening.
 Other: questionnaire administration
Ancillary studies
Other: lymphedema management

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.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019512

Locations
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Abass Alavi Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Alavi, Abass, Abramson Cancer Center of The University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01019512     History of Changes
Other Study ID Numbers: UPCC 02109, NCI-2009-01415
Study First Received: November 23, 2009
Last Updated: March 23, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Breast Diseases
Lymphatic Diseases
 Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on March 01, 2015