Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000742572
Ethics application status
Approved
Date submitted
22/05/2015
Date registered
20/07/2015
Date last updated
20/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of compression on lymphoedema in women with breast cancer: a pilot study
Scientific title
The effect of compression on lymphoedematous tissue in women with lymphoedema secondary to treatment for breast cancer: a pilot study
Secondary ID [1] 286788 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoedema secondary to breast cancer 295164 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295406 295406 0 0
Physiotherapy
Cancer 295533 295533 0 0
Breast
Cardiovascular 295534 295534 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women will undergo two MRI scans on their arm - one while wearing their own compression garment and the other without. Compression garments will not be provided as a part of the study. The current recommendation is for compression to be used continuously (International Lymphoedema Framework, 2012). For persons with upper limb LE, the recommendation is to use at least 30 to 40 mmHg (Class II garment).
Intervention code [1] 291945 0
Rehabilitation
Intervention code [2] 292058 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295143 0
Volume of extracellular fluid in the lymphoedematous region, assessed from the MRI scan
Timepoint [1] 295143 0
At baseline and after one week.
Secondary outcome [1] 314849 0
Description of pressure exerted by compression garment on the lymphoedematous region using spatial pressure maps (Tekscan, South Boston, MA)
Timepoint [1] 314849 0
Only assessed at baseline

Eligibility
Key inclusion criteria
- clinically detectable unilateral secondary upper limb lymphoedema arising from treatment of breast cancer using accepted diagnostic thresholds for bioimpedance spectroscopy (BIS) or volume measurements;
- if they can attend Spectrum Imaging, Randwick on one or two occasions, and
- if they understand English and consent to participate, and
- if they currently use compression garments to manage their lymphedematous arm
Minimum age
18 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
if they do not have clinically detectable lymphoedema on the day of testing, if they have a pacemaker or other metal implant, if they suffer from claustrophobia; if they are unable to lie on their stomach with their arms above their head or if they have primary or bilateral upper limb lymphoedema.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study will involve up to two visits for repeat MRI scans. For one visit, we ask that that the participant wears their garment; for the second visit, we ask that they do not put their garment on that day until after the scan. If they are only able to attend one visit, we ask that they do wear their garment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation of order of wearing the garment in case they choose not to come back the second time.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study providing proof of concept. Digital image correlation will be used to measure strains on the surfaces of the compression sleeve while applied to the affected and the contralateral limb. In this way, the prevailing surface pressure of the affected limb can be compared to the contralateral while also evaluating the compression abatement via the compression sleeve.
MRI data: The quantity of adipose tissue, fibrosis, and epifascial lakes will be quantified using PD images and segmentation software (AnalyzeDirect). The Volume Render module is used to measure volume of the oedematous tissue in three dimensions. DWI data will be analyzed with both Gaussian and non-Gaussian models using in-house software written in Matlab.
Magnetic resonance elastography data will be analysed using in-house custom software written in C++, to derive tissue shear modulus.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/07/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291324 0
University
Name [1] 291324 0
University of Sydney
Country [1] 291324 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Faculty of Health Sciences
75 East Street
Lidcombe 2141
Country
Australia
Secondary sponsor category [1] 290009 0
University
Name [1] 290009 0
University of New South Wales
Address [1] 290009 0
The Graduate School of Biomedical Engineering
UNSW Australia
SYDNEY
NSW 2052
AUSTRALIA
Country [1] 290009 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292891 0
University of Sydney
Ethics committee address [1] 292891 0
Office of Research Integrity
Research Portfolio
Lv 2
Margaret Telfer Building (K07)
The University of Sydney
NSW 2006
Ethics committee country [1] 292891 0
Australia
Date submitted for ethics approval [1] 292891 0
13/04/2015
Approval date [1] 292891 0
01/06/2015
Ethics approval number [1] 292891 0
Project No: 2015/305

Summary
Brief summary
This study aims to describe the effect of limb compression on lymphoedema in terms of fluid distribution and soft tissue structure changes using MRI.

Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a clinically detectable unilateral secondary upper limb lymphoedema arising from treatment of breast cancer. This diagnosis must be made using accepted diagnostic thresholds for bioimpedance spectroscopy (BIS) or volume measurements. You must also currently use a compression garment for management of your lymphoedema.

All participants enrolled in this study will have at least one MRI scan while wearing the upper limb compression garment. Depending on participant availability, a second MRI scan on a separate visit may also be performed where participants do not wear the compression garment for that day. It is hoped that this study will contribute to a better understanding of how different levels of compression can be used in control of the lymphoedema.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57530 0
Prof Sharon Kilbreath
Address 57530 0
University of Sydney
Faculty of Health Sciences
75 East Street
Lidcombe, NSW 2141
Country 57530 0
Australia
Phone 57530 0
+61293519272
Fax 57530 0
Email 57530 0
sharon.kilbreath@sydney.edu.au
Contact person for public queries
Name 57531 0
Miss Lanni Lin
Address 57531 0
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe NSW 2141
Country 57531 0
Australia
Phone 57531 0
+61290367309
Fax 57531 0
Email 57531 0
lanni.lin@sydney.edu.au
Contact person for scientific queries
Name 57532 0
Prof Sharon Kilbreath
Address 57532 0
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe NSW 2141
Country 57532 0
Australia
Phone 57532 0
+61293519272
Fax 57532 0
Email 57532 0
sharon.kilbreath@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.