NCT01954654

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

September 29, 2013

Last Update Submit

October 6, 2013

Conditions

Breast CancerLymphedema

Outcome Measures

Primary Outcomes (1)

  • Change of excess limb volume (ELV)

    ELV in the affected arm compared to the non-affected arm. ELV described as both absolute volume in ml and relative volume in percent

    8 weeks follow-up

Secondary Outcomes (2)

  • Changes in arm disability

    8 weeks follow-up

  • Changes in subjective symptoms (pain, tension, and heaviness)

    8 weeks follow-up

Study Arms (2)

Accelerated treatment

EXPERIMENTAL
Device: Custom-made compression sleeve and -gauntletOther: Educational information, recommendation and instruction

Standard treatment

ACTIVE COMPARATOR
Device: Custom-made compression sleeve and -gauntletOther: Educational information, recommendation and instruction

Interventions

Custom-made compression sleeve and -gauntletDEVICE

Device: Compression garments worn for a minimum of six hours per day

Also known as: Jobst Elvarex
Accelerated treatmentStandard treatment
Educational information, recommendation and instructionOTHER

Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow

Accelerated treatmentStandard treatment

Eligibility Criteria

Age18 Years - 95 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen

Aarhus, Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Mette B Jerver

CONTACT

+45 78 46 22 10Mette.Brodersen.Jerver@auh.rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

September 29, 2013

First Posted

October 7, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2015

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

DK(1)