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Trial registered on ANZCTR


Registration number
ACTRN12619000263190
Ethics application status
Approved
Date submitted
16/01/2019
Date registered
20/02/2019
Date last updated
7/05/2019
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of massage and compression for treatment of head and neck lymphoedema after head and neck cancer treatment.
Scientific title
A randomised controlled trial comparing manual lymphatic drainage and compression in the management of head and neck lymphoedema following head and neck cancer treatment.
Secondary ID [1] 297097 0
None
Universal Trial Number (UTN)
U1111-1226-8447
Trial acronym
HIBISCUS
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Head and neck lymphoedema 311109 0
head and neck cancer 311293 0
Condition category
Condition code
Cancer 309739 309739 0 0
Head and neck
Cardiovascular 309911 309911 0 0
Diseases of the vasculature and circulation including the lymphatic system
Physical Medicine / Rehabilitation 309912 309912 0 0
Occupational therapy
Physical Medicine / Rehabilitation 309913 309913 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study employs a randomised controlled trial comparing two therapy modalities for head and neck lymphoedema management. All participants will undergo the same battery of assessments including imaging of their head and neck lymphatics with near infra-red fluorescence lymphatic imaging. Participants will be randomised to an intervention group.

Those randomised to group A will receive treatment with compression therapy, a common component of standard care for head and neck lymphoedema treatment. They will be fitted with a compression neck/face support and a flat foam insert by an occupational therapist or physiotherapist. They will be provided with written and verbal instructions and will be requested to apply the compression themselves as tolerated gradually increasing to 8 hours in every 24 hours. The duration of the intervention is 6 weeks.

Those randomised to group B will receive treatment with 30mins manual lymphatic drainage twice weekly from an occupational therapist or physiotherapist and will be requested to complete the same sequence for 30min once daily at home. The duration of the intervention is 6 weeks.

Irrespective of group allocation, participants will also be educated about head and neck lymphoedema and will receive a program of active exercises. Exercises will involve active range of motion movements of the face (contraction and relaxation of the lips, nose and eyes), neck (bending forwards, backwards, turning to the side and tilting to the side), and shoulders (circles and rotations) and participants will be requested to complete these 5-10 times per session for 2 sessions per day for the 6 weeks of the program. The exercises will be completed by the participant alone as a part of their self management training.

During the first treatment session all participants will receive 1-1 training in self management for active exercises and either compression or manual lymphatic drainage. They will also receive written instructions to guide this self management. Self management training will be reviewed at each therapy appointment. Participants will be requested to monitor their adherence to self-management in a diary. Fidelity of the intervention (attended sessions, intervention delivered) will be recorded by the treating team.

Between weeks 6-12 participants will continue self management as required.

All participants will attend a 12 week follow up face-to-face assessment. This will be the last data collection point although participants may continue to receive therapy at the Princess Alexandra Hospital Lymphoedema Service if clinically indicated.

During the trial, participants who wish to withdraw will be offered standard combined modality therapy through the Princess Alexandra Hospital Lymphoedema Service.
Intervention code [1] 313368 0
Rehabilitation
Intervention code [2] 313484 0
Treatment: Other
Comparator / control treatment
Manual lymphatic drainage (comparator) will be compared with compression for the management of head and neck lymphoedema
Control group
Active

Outcomes
Primary outcome [1] 318702 0
Change in tissue dielectric constant readings (as indicative of a reduction in head and neck lymphoedema)
Timepoint [1] 318702 0
6 weeks
Primary outcome [2] 318851 0
Feasibility of conducting a randomised controlled trial comparing compression and manual lymphatic drainage in the management of head and neck lymphoedema.
Timepoint [2] 318851 0
6 weeks
Secondary outcome [1] 365768 0
Change in tape measurements (as indicative of head and neck lymphoedema)
Timepoint [1] 365768 0
12 weeks

Eligibility
Key inclusion criteria
• >18 years of age
• A previous diagnosis of oral, nasopharyngeal, oropharyngeal, laryngeal, or hypopharyngeal cancer treated with chemoradiation, postoperative radiation or definitive radiation with curative intent
• Life expectancy >12months
• Able to provide informed written consent
• MD Anderson Cancer Centre (MDACC) HNL rating >1 indicating soft visible oedema; no pitting, reversible

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Cancer recurrence
• Previous radiotherapy and/or surgery to the neck, oral, pharyngeal, or laryngeal anatomic structures
• Pharyngolaryngectomy or laryngectomy
• Co-morbidity factors that may result in head and neck oedema and/or lymphoedema, or impact their swallowing and voice function; such as stroke, head and neck trauma, or neurological degenerative diseases.
• Unable to attend follow up appointments at the study site
• Facial hair precluding completion of external lymphoedema assessment
• NIRFLI imaging only: Allergic to indocyanine green, sodium iodide or iodine, over-active thyroid, benign tumours of the thyroid, previous known side effects from indocyanine green injections, kidney failure.

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)
Allocation will be concealed in sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be utilised to describe the cohorts, including patient characteristics, Head and neck cancer disease and treatment data, and lymphoedema disease and treatment data. Feasibility will be examined descriptively, and group comparisons will be conducted using generalised linear models (patient as random factor to account for non-independence of repeated measures). Group by time interactions will also be considered for this study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12920 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 25395 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 301664 0
Charities/Societies/Foundations
Name [1] 301664 0
Princess Alexandra Hospital Research Foundation
Address [1] 301664 0
Ipswich Rd
Woolloongabba, QLD, 4102
Country [1] 301664 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Ipswich Rd
Woolloongabba, QLD, 4102
Country
Australia
Secondary sponsor category [1] 301378 0
None
Name [1] 301378 0
Address [1] 301378 0
Country [1] 301378 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302384 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 302384 0
Metro South Health HREC
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 302384 0
Australia
Date submitted for ethics approval [1] 302384 0
17/01/2019
Approval date [1] 302384 0
29/04/2019
Ethics approval number [1] 302384 0
HREC/2019/QMS/47451

Summary
Brief summary
This study will investigate the treatment of head and neck lymphoedema in a head and neck cancer population.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have a previous diagnosis of oral, nasopharyngeal, oropharyngeal, laryngeal, or hypopharyngeal cancer treated with chemoradiation, postoperative radiation or definitive radiation with curative intent.

Study details
All participants will undergo measurements and lymphatic imaging of the head and neck using near infra-red fluorescence lymphatic imaging, in order to examine swelling. Participants will be randomly allocated (by chance) to receive either compression therapy or manual lymphatic drainage over a period of 6 weeks. Compression therapy involves wearing a compression neck/face support and a flat foam insert for up to 8 hours per 24 hours. Manual lymphatic drainage will be administered by a therapist twice a week and participants will also be trained to self-administer this therapy at home.

Participants in both treatment groups will be evaluated after 6 weeks and 12 weeks of therapy in order to evaluate effect on lymphoedema. It is hoped that this study will help us to determine the most effective therapy modality to treat head and neck lymphoedema and will provide valuable information to inform future studies of this type.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 90046 0
Dr Amanda Pigott
Address 90046 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 90046 0
Australia
Phone 90046 0
+61 7 3176 5008
Fax 90046 0
Email 90046 0
amanda.pigott@uq.edu.au
Contact person for public queries
Name 90047 0
Dr Amanda Pigott
Address 90047 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 90047 0
Australia
Phone 90047 0
+61 7 3176 5008
Fax 90047 0
Email 90047 0
amanda.pigott@uq.edu.au
Contact person for scientific queries
Name 90048 0
Dr Amanda Pigott
Address 90048 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 90048 0
Australia
Phone 90048 0
+61 7 3176 5008
Fax 90048 0
Email 90048 0
amanda.pigott@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain participant privacy, summary data only will be disseminated
What supporting documents are/will be available?
No other documents available
Summary results
No Results