Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effectiveness of Accelerated Intervention With Compression Sleeve in Mild and Moderate Breast Cancer-related Lymphedema

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Mette Brodersen Jerver, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01954654
First received: September 29, 2013
Last updated: October 6, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to determine whether accelerated treatment with custom-made compression sleeve is more effective than standard procedure in the treatment of mild and moderate arm lymphedema secondary to primary cancer treatment.


Condition Intervention
Breast Cancer
Lymphedema
Device: Custom-made compression sleeve and -gauntlet
Other: Educational information, recommendation and instruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Accelerated Intervention With Custom-made Compression Sleeve in Women With Mild and Moderate Arm Lymphedema Secondary to Breast Cancer Treatment

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Change of excess limb volume (ELV) [ Time Frame: 8 weeks follow-up ] [ Designated as safety issue: No ]
    ELV in the affected arm compared to the non-affected arm. ELV described as both absolute volume in ml and relative volume in percent


Secondary Outcome Measures:
  • Changes in arm disability [ Time Frame: 8 weeks follow-up ] [ Designated as safety issue: No ]
    Measured with Disabilities of Arm, Shoulder, and Hand (DASH)

  • Changes in subjective symptoms (pain, tension, and heaviness) [ Time Frame: 8 weeks follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: October 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accelerated treatment Device: Custom-made compression sleeve and -gauntlet
Device: Compression garments worn for a minimum of six hours per day
Other Name: Jobst Elvarex
Other: Educational information, recommendation and instruction
Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow
Active Comparator: Standard treatment Device: Custom-made compression sleeve and -gauntlet
Device: Compression garments worn for a minimum of six hours per day
Other Name: Jobst Elvarex
Other: Educational information, recommendation and instruction
Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow

Detailed Description:

Use of a custom-made compression sleeve is an initial treatment of mild and moderate arm lymphedema secondary to primary breast cancer treatment. The compression sleeve improves the flow of lymph fluid out of the arm, reduces the swelling, and prevents progression of the lymphedema in the future.

Early intervention is recommended though early is not well-defined in literature. The purpose of this study is to evaluate reduction of excess limb volume and changes in arm disability and clinical symptoms in accelerated treatment with compression sleeve compared to standard treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be refered for the first time due to unilateral arm lymphedema secondary to primary unilateral breast cancer treatment
  • Participants must be ≥ 2 months after chemo- and radiotherapy
  • Participants must have ELV ≥10% and < 30% and/or > 2 cm difference between the circumference of the two arms at minimum one circumference due to lymphedema
  • Participants must be motivated for treatment with compression sleeve and -gauntlet
  • Participants live in and around Aarhus, Denmark

Exclusion Criteria:

  • Known metastatic disease
  • Contraindication for treatment with compression sleeve
  • Upper extremity deep venous thrombosis
  • Previously use of compression sleeve
  • Known contact allergy to latex
  • Unable to fill in questionnaire and/or comply with treatment due to lacking Danish language skills, mental state or psychological condition
  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: NCT01954654

Contacts
Contact: Mette B Jerver +45 78 46 22 10 Mette.Brodersen.Jerver@auh.rm.dk

Locations
Denmark
Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen Recruiting
Aarhus, Denmark, 8000
Contact: Mette B Jerver    +45 78 46 22 10    Mette.Brodersen.jerver@auh.rm.dk   
Principal Investigator: Mette B Jerver         
Sponsors and Collaborators
Mette Brodersen Jerver
  More Information

No publications provided

Responsible Party: Mette Brodersen Jerver, Physiotherapist, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01954654     History of Changes
Other Study ID Numbers: 2007-58-0010
Study First Received: September 29, 2013
Last Updated: October 6, 2013
Health Authority: Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on November 24, 2014