Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001689268p
Ethics application status
Submitted, not yet approved
Date submitted
25/09/2018
Date registered
12/10/2018
Date last updated
22/05/2019
Date data sharing statement initially provided
22/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
HI-LO Trial in Lymphoedema – What is the optimal pressure for compression garments prescribed to women with upper limb lymphoedema
Scientific title
High versus Low – What is the optimal pressure for compression garments prescribed to women with mild to moderately severe lymphoedema? A pilot randomised controlled trial
Secondary ID [1] 295799 0
Nil known
Universal Trial Number (UTN)
U1111-1218-9697
Trial acronym
Hi-Lo Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary arm lymphoedema 309231 0
Condition category
Condition code
Cancer 308106 308106 0 0
Breast
Physical Medicine / Rehabilitation 308107 308107 0 0
Physiotherapy
Physical Medicine / Rehabilitation 308108 308108 0 0
Occupational therapy
Cardiovascular 308769 308769 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Participants will be randomised to receive a low (15 - 25mmHg) or high (30 to 40mmHg) compression garment. All participants will wear the garments for 12 hours per day for 6 months and they will be provided 2 garments each. Participants will be measured for a Juzo sleeve and gauntlet by a certified lymphoedema therapist. If participants fit within measures for a ready to wear garment they will be provided with this, if they do not, a custom made sleeve and gauntlet will be provided.
- Standardised, validated assessments will be conducted face to face at baseline and 6 months including: arm volume assessed by circumference-based measures and bioimpedance spectroscopy; patient-reported outcomes assessed by the Lymphoedema Quality of Life (ARM) questionnaire; tissue compliance assessed with the pitting test; lymphatic functioning, assessed by lymphoscintigraphy; and upper limb morphology, including dermal and subdermal thickness assessed by ultrasound, and fat volume within the lymphoedematous limb, assessed by both SPECT/CT and MRI.
- Adherence to wearing the compression garment and garment care will be assessed by a weekly online questionnaire.
- Pressure exerted by the compression garment will be checked (face to face) at 1 week and 2 and 4 months post baseline measures by a certified lymphoedema therapist.
Intervention code [1] 312130 0
Treatment: Devices
Comparator / control treatment
High level compression garment (30 to 40mmHg) worn for 12 hours per day for 6 months
Control group
Active

Outcomes
Primary outcome [1] 307082 0
Percent change in limb volume, derived by measurements of limb circumference.
Timepoint [1] 307082 0
Baseline and 6 months after randomisation
Secondary outcome [1] 350594 0
Volume of extracellular fluid, assessed with bioimpedance spectroscopy
Timepoint [1] 350594 0
Baseline and 6 months after randomisation
Secondary outcome [2] 350595 0
Tissue compliance assessed with the pitting test
Timepoint [2] 350595 0
Baseline and 6 months after randomisation
Secondary outcome [3] 350596 0
Patient reported outcomes using Lymphoedema Quality of Life Study (LYMQOL)
Timepoint [3] 350596 0
Baseline and 6 months after randomisation
Secondary outcome [4] 350597 0
Lymphatic functioning assessed with lymphoscintigraphy
Timepoint [4] 350597 0
Baseline and 6 months post randomisation
Secondary outcome [5] 350598 0
Upper limb morphology including fat volume assessed by MRI
Timepoint [5] 350598 0
Baseline and 6 months after randomisation
Secondary outcome [6] 352768 0
Dermal and subdermal thickness using ultrasound (composite outcome)
Timepoint [6] 352768 0
Baseline and 6 months after randomisation
Secondary outcome [7] 352769 0
Upper limb morphology including fat volume assessed by SPECT/CT
Timepoint [7] 352769 0
Baseline and 6months post randomisation

Eligibility
Key inclusion criteria
- Diagnosed with secondary arm lymphoedema (LE) equal or greater than 6 months but less than 5 years previously;
- Secondary arm LE confirmed by arm measurements that surpass the 2 standard deviation thresholds for circumference measurements;
- Completed any adjuvant cancer therapy (excluding hormone treatments) equal or greater than 6 months previously.
- understand English.
Minimum age
18 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- choose not to be randomised to either the high or low pressure compression garment.
- have a relative interlimb arm difference, assessed from wrist to 40cm proximal to the wrist, that is equal or greater than 30%;
- have received decongestive therapy (ie massage and bandaging) within the last 6 months;
- have a pacemaker, metal implant, suffer from claustrophobia, are unable to lie on their stomach with arms above their head or any other MRI-incompatible implant;
- have primary or bilateral upper limb LE; and/or
- are not available for ongoing assessments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered opaque envelopes with the group allocation sealed inside.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1 ratio to receive either low or high compression garments. The randomisation list will be computer generated by a person not involved with the project
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is designed as a pilot RCT to inform a larger studies. The pilot study will be used to identify what is the sample size required.
Changes will be analysed using descriptive analysis including means/standard deviations or median and interquartile range. Data extracted from the different imaging approaches will be compared using paired t-tests and 95% confidence intervals and correlations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2019
Actual
Date of last participant enrolment
Anticipated
8/04/2020
Actual
Date of last data collection
Anticipated
12/10/2020
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300390 0
Government body
Name [1] 300390 0
Sydney Vital, Translational Cancer Research
Country [1] 300390 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Faculty of Health Sciences
75 East Street
Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 299844 0
None
Name [1] 299844 0
None
Address [1] 299844 0
Country [1] 299844 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301199 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301199 0
NSLHD Research Office
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 301199 0
Australia
Date submitted for ethics approval [1] 301199 0
27/08/2018
Approval date [1] 301199 0
24/10/2018
Ethics approval number [1] 301199 0
RESP18/245
Ethics committee name [2] 303423 0
University of Sydney Research Integrity and Ethics
Ethics committee address [2] 303423 0
Level 3 Administration Building (F23)
University of Sydney
NSW 2006
Ethics committee country [2] 303423 0
Australia
Date submitted for ethics approval [2] 303423 0
18/03/2019
Approval date [2] 303423 0
07/05/2019
Ethics approval number [2] 303423 0
2019/262

Summary
Brief summary
The purpose of this study is to provide some preliminary data on the impact of different levels of compression on lymphoedema.

Who is it for?
You may be eligible for this study if you are over 18, have completed breast cancer therapy (except hormone treatments) at least 6 months ago and have been diagnosed with secondary arm lymphoedema.

Study details
Participants in this study will be randomised (by chance) into two groups. All participants will wear a compression garment for 12 hours a day for 6 months and will be a sleeve and gauntlet. You will be measured for these by a certified lymphoedema therapist. One group will wear a high compression garment, and the other will wear a low compression garment. Participants will have the garments checked after one week, two months and 4 months of wear; as well as have some scans, undergo some measurements and complete a questionnaire before and after the 6 month trial.

It is hoped this research will provide important preliminary information as to what the optimal level of compression is for people with secondary arm lymphoedema.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86198 0
Prof Sharon Kilbreath
Address 86198 0
University of Sydney
Faculty of Health Sciences
75 East Street
Lidcombe, NSW 2141
Country 86198 0
Australia
Phone 86198 0
+61 2 9351 9272
Fax 86198 0
+61 2 9351 9601
Email 86198 0
[email protected]
Contact person for public queries
Name 86199 0
Ms Nicola Fearn
Address 86199 0
University of Sydney
Faculty of Health Sciences
75 East Street
Lidcombe, NSW 2141
Country 86199 0
Australia
Phone 86199 0
+61435625365
Fax 86199 0
Email 86199 0
[email protected]
Contact person for scientific queries
Name 86200 0
Prof Sharon Kilbreath
Address 86200 0
University of Sydney
Faculty of Health Sciences
75 East Street
Lidcombe, NSW 2141
Country 86200 0
Australia
Phone 86200 0
+61 2 9351 9272
Fax 86200 0
+61 2 9351 9601
Email 86200 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot study and the protocol and results will be used to inform future grant applications by the team.


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.