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Trial registered on ANZCTR


Registration number
ACTRN12617001215314p
Ethics application status
Not yet submitted
Date submitted
14/08/2017
Date registered
21/08/2017
Date last updated
21/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of Complete Decongestive Therapy including an occupational therapy lymphoedema exercise protocol for individuals recovering from head and neck cancer treatment

Scientific title
The effectiveness of Complete Decongestive Therapy including an occupational therapy lymphoedema exercise protocol for individuals recovering from head and neck cancer treatment

Secondary ID [1] 292646 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 304378 0
Lymphoedema 304379 0
Condition category
Condition code
Cancer 303706 303706 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with head and neck cancer-related lymphoedema (HNCRL), attending the Sir Charles Gardiner Hospital (SCGH) will be purposively recruited for this study. Upon recruitment, participants will be asked to undertake a demographic questionnaire including questions regarding age and gender. Medical information which will be obtained will include primary tumor type, type of treatment for tumor, dates since treatment and other health professionals being seen. All participants will then undergo pre-intervention assessments (measured using the ALOHA protocol (tape measurement), lymphoedema will be graded through MD Anderson lymphoedema grading scale) and complete self-reported questionnaire ( EORTC-H&N 43). Photographs will be taken of lymphoedema for patient satisfaction. After baseline measures are taken, participants will be randomly allocated through a blocking system, to CDT protocol group or Ex protocol group. Both groups will receive SCGH usual treatment of CDT. Ex protocol group will receive an added head and neck lymphoedema specific exercise program to complete 3-5 times a day at home on top of usual care for 6 weeks. Both CDT protocol and Ex protocol will recive their therapy by the treating lymphoedema occupational therapist at Sir Charles Gardiner Hospital.
Once allocated to a specific group, either Ex or CDT protocol group, the treating occupational therapist. will tell participant which arm of the study they have been allocated to. OT will then administer treatment and education about what they are expected to do at home

The CDT protocol group will only receive the usual head and neck lymphoedema treatment provided by Sir Charles Gardiner Hospital. Usual care involves one face to face CDT training session for self-administration and education techniques, including (1) self-managed manual lymph drainage (MLD); (2) education on functional movement; (3) use of compression garments (CG) to reduce swelling from treatment; (4) skin care (scar management and hydration).
Pre-intervention evaluation, training session, and post-intervention evaluation will be performed at Sir Charles Gardiner Hospital in the cancer clinic. All participants will perform self-managed- CDT at home for the duration of the study. Treating OT will educate each participant on self-managed MLD techniques. Self-managed manual lymph drainage will be performed by the participant daily to redirect lymphatic fluid from the cervical region to the bilateral axillary lymph node beds. Based on scar patterns and severity, anterior and lateral neck drainage channels will be used if scarring is absent or insignificant and posterior neck and trunk channels will be used for participants with marked scarring. Current protocol at SCGH implements exercise in the form of functional movements. Participants are directed to move their head and neck when performing functional tasks within pain and range of motion limitations. Sir Charles Gardener Hospital (SCGH) current protocol uses a commercially available ‘Marena’ recovery facial mask (compression garment). Education will be provided on how to don and doff compression garment. Participants will be instructed to wear the compression garment (CG) for a minimum of two to four hours per day after completion of self-managed MLD to maintain even pressure. Participants will be instructed to wear CG as much as possible when at home including when sleeping. Participants will be advised they are not expected to wear CG away from their home. Participants will then be educated regarding skin care principles to minimise risk of infection. Education is given on ensuring the skin is kept clean, well moisturised and to avoid sunburn. Each participant is treated on individual need basis. If scars are present, the use of contact media such as silicon is applied and scar massage techniques are taught. A participant diary will be given to each participant in CDT protocol for recording time use in CG and types of exercise performed. Participant diary is expected to be filled out daily for the six-week period.

Participants allocated to intervention group will receive usual care outlined above and introduced to Ex protocol to perform daily while wearing the compression garment. The Ex protocol includes 15 exercises comprising of deep breathing, shoulder movement, neck movements (flexion; extension; lateral flexion), tongue movements, facial movements, and mouth movements with voice activation. Below is the exact Ex protocol
1. Deep breathing: five deep breaths, each held for a slow count of 2
2. Shrug shoulders up and down. Repeat five times
3. Shrug shoulders back (to expand chest) and relax. Repeat five times
4. Face forward, then turn head to left as far as it will go, then back to the centre and round to the right as far as it will go and back to centre. Repeat five times
5. Facing forward, tilt head back as far as you can comfortably go and then bring chin down to chest (squashing the collar) and back to start point. Repeat five times
6. Tilt left ear to shoulder and then right ear to shoulder. Repeat five times
7. Shrug shoulders up and down. Repeat five times
8. Shrug shoulders back (to expand chest) and relax. Repeat five times
9. Poke tongue out slowly, as far as it will go, and slowly pull tongue back in. Repeat five times
10. Mouth (whisper) vowel sounds, slowly and exaggerated = a, e, i, o, u. Repeat five times
11. Smile (as if having portrait photo taken) and hold for 2, then relax. Repeat five times
12. Scrunch eyes tight, hold for 2 and relax. Repeat five times
13. Shrug shoulders up and down. Repeat five times
14. Shrug shoulders back (to expand chest) and relax. Repeat five times
15. Deep breathing: five deep breaths, each held for a slow count of 2
The treating lymphoedema OT will demonstrate the full ten-minute Ex program facing the participant. Each exercise will be demonstrated to ensure each participant feels comfortable performing Ex at home. The Ex protocol is to be completed 3-5 times per day at home for 6 weeks by the participant.
A participant diary will be given to each participant in Ex protocol group and told to record time use in CG and amount of Ex performed each day. Participant diary is expected to be filled out daily for the six-week period. At the end of six weeks, all participants (CDT protocol and Ex protocol) will return to SCGH and perform post intervention evaluation. Participants will return completed diary after post evaluation. Post intervention, exercise protocol will be available to participants in CDT protocol group.
intervention will span over a 6 week period. Participants are expected to attend 2x 1-hour sessions over the 6 week period. one at 0 weeks ( pre intervention) and 6 weeks (post intervention.
Patient adherence will not be assessed in this trial. Education at initial appointment will be given to participant to ensure that they understand adherence is important to the study process.
Intervention code [1] 298885 0
Treatment: Other
Comparator / control treatment
The control group is an active control. The Complete Decongestive Therapy (CDT) protocol group will only receive the usual head and neck lymphoedema treatment provided by SCGH. Usual care involves one CDT training session for self-administration and education techniques, including (1) self-managed manual lymph drainage (MLD); (2) education on functional movement; (3) use of compression garments (CG) to reduce swelling from treatment; (4) skin care (scar management and hydration).

Participants will perform self-managed- CDT at home for the duration of the study. In initial education session treating OT will educate each participant on self-managed MLD techniques. Self-managed manual lymph drainage will be performed by the participant once a day to redirect lymphatic fluid from the cervical region to the bilateral axillary lymph node beds. Based on scar patterns and severity, anterior and lateral neck drainage channels will be used if scarring is absent or insignificant and posterior neck and trunk channels will be used for participants with marked scarring. Current protocol at SCGH implements exercise in the form of functional movements. Participants are directed to move their head and neck when performing functional tasks within pain and range of motion limitations. Sir Charles Gardener Hospital (SCGH) current protocol uses a commercially available ‘Marena’ recovery facial mask (compression garment). Education will be provided on how to don and doff compression garment. Participants will be instructed to wear the compression garment (CG) for a minimum of two to four hours per day after completion of self-managed MLD to maintain even pressure. Participants will be instructed to wear CG as much as possible when at home including when sleeping. Participants will be advised they are not expected to wear CG away from their home. Participants will then be educated regarding skin care principles to minimise risk of infection. Education is given on ensuring the skin is kept clean, well moisturised and to avoid sunburn. Each participant is treated on individual need basis. If scars are present, the use of contact media such as silicon is applied and scar massage techniques are taught. A participant diary will be given to each participant in CDT protocol for recording time use in CG and types of exercise performed. Participant diary is expected to be filled out daily for the six-week period.
The training session will be within a 40-minute appointment and be delivered by the treating occupational therapists (OT).
Control group
Active

Outcomes
Primary outcome [1] 303086 0
Amount of Lymphoedema. Determined by using ALOHA tape measurment protocol.
Timepoint [1] 303086 0
At 0 weeks (pre intervention) and 6 weeks (post intervention
Primary outcome [2] 303087 0
Body image, swallowing and health and well-being using the EORCT H&N 43.
This is a composite primary outcome.
Timepoint [2] 303087 0
at 0 weeks (pre intervention) and at 6 weeks (post intervention)
Primary outcome [3] 303088 0
Grade of Lymphoedema. determined by using the MD Anderson head and neck rating scale.
Timepoint [3] 303088 0
At 0 weeks (pre intervention) and 6 weeks (post intervention)
Secondary outcome [1] 337863 0
total time of compression garment wear assessed by review of patient diary
Timepoint [1] 337863 0
at 6 weeks (end of intervention)
Secondary outcome [2] 337942 0
the amount of exercises performed in the intervention group. This will be understood from the participant diary
Timepoint [2] 337942 0
end of 6 weeks ( post intervention)

Eligibility
Key inclusion criteria
Inclusion criteria into the proposed study includes the following (1) > 18 years or older; (2) English spoken and able to provide written and informed consent; (3) must be referred to SCGH for having head and neck cancer related lymphoedema (HNCRL); and (4) willingness to undergo baseline and follow up assessments at SCGH facilities.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if treated for HNC but have no secondary lymphoedema.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/12/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 297275 0
University
Name [1] 297275 0
Curtin University
Country [1] 297275 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Western Australia (WA) 6102
Country
Australia
Secondary sponsor category [1] 296251 0
Hospital
Name [1] 296251 0
Sir Charles Gardiner Hospital
Address [1] 296251 0
Hospital Avenue
Nedlands 6009
Western Australia
Country [1] 296251 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298392 0
Curtin University Human Research Ethics Committee and Sir Charles Gardiner Hospital Human Research Ethics Committee
Ethics committee address [1] 298392 0
Ethics committee country [1] 298392 0
Date submitted for ethics approval [1] 298392 0
29/08/2017
Approval date [1] 298392 0
Ethics approval number [1] 298392 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76930 0
Dr Courtenay Harris
Address 76930 0
Curtin University (Bentley campus) Kent Street, Bentley, Western Australia, 6102
Country 76930 0
Australia
Phone 76930 0
+61 8 9266 3683
Fax 76930 0
Email 76930 0
C.Harris@curtin.edu.au
Contact person for public queries
Name 76931 0
Tess McLaughlin
Address 76931 0
Curtin University (Bentley campus) Kent Street, Bentley, Western Australia, 6102
Country 76931 0
Australia
Phone 76931 0
+61 434645925
Fax 76931 0
Email 76931 0
18264564@student.curtin.edu.au
Contact person for scientific queries
Name 76932 0
Tess McLaughlin
Address 76932 0
Curtin University (Bentley campus) Kent Street, Bentley, Western Australia, 6102
Country 76932 0
Australia
Phone 76932 0
+61 434645925
Fax 76932 0
Email 76932 0
18264564@student.curtin.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
SourceTitleYear of PublicationDOI
EmbaseA randomized pilot study on self-management in head and neck lymphedema.2020https://dx.doi.org/10.1002/lio2.455
N.B. These documents automatically identified may not have been verified by the study sponsor.