ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Head and Neck Cancer

Lymphoedema

Condition category

Condition code

Cancer

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]

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]

Amount of Lymphoedema. Determined by using ALOHA tape measurment protocol.

Timepoint [1]

At 0 weeks (pre intervention) and 6 weeks (post intervention

Primary outcome [2]

Body image, swallowing and health and well-being using the EORCT H&N 43.
This is a composite primary outcome.

Timepoint [2]

at 0 weeks (pre intervention) and at 6 weeks (post intervention)

Primary outcome [3]

Grade of Lymphoedema. determined by using the MD Anderson head and neck rating scale.

Timepoint [3]

At 0 weeks (pre intervention) and 6 weeks (post intervention)

Secondary outcome [1]

total time of compression garment wear assessed by review of patient diary

Timepoint [1]

at 6 weeks (end of intervention)

Secondary outcome [2]

the amount of exercises performed in the intervention group. This will be understood from the participant diary

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Kent Street, Bentley, Western Australia (WA), 6102

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Kent Street, Bentley, Western Australia (WA) 6102

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Sir Charles Gardiner Hospital

Address [1]

Hospital Avenue
Nedlands 6009
Western Australia

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Curtin University Human Research Ethics Committee and Sir Charles Gardiner Hospital Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

29/08/2017

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Aim
The aim of this study is to determine the effectiveness of a lymphoedema exercise protocol in individuals recovering from head and neck cancer treatment.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, treated for head and neck cancer at the Sir Charles Gardiner Hospital and experiencing head and neck cancer related lymphoedema.

Study details
Participants in this study are randomly allocated (by chance to one of two groups. Participants in one group will receive a complete decongestive therapy protocol (usual treatment) for 6 weeks, whilst participants in the other group will receive an exercise protocol in addition to usual treatment for 6 weeks.

Assessments (stage and amount of lymphoedema; body image; swallowing; health and wellbeing) will administered pre-intervention (0 weeks) and at post intervention (6 weeks).

The proposed study will expand the limited knowledge of lymphoedema for people recovering from head and neck cancer and determine the effectiveness of complete decongestive therapy in conjunction with an exercise protocol.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Courtenay Harris

Address

Curtin University (Bentley campus) Kent Street, Bentley, Western Australia, 6102

Country

Australia

Phone

+61 8 9266 3683

Fax

[email protected]

Contact person for public queries

Name

Miss Tess McLaughlin

Address

Curtin University (Bentley campus) Kent Street, Bentley, Western Australia, 6102

Country

Australia

Phone

+61 434645925

Fax

[email protected]

Contact person for scientific queries

Name

Miss Tess McLaughlin

Address

Curtin University (Bentley campus) Kent Street, Bentley, Western Australia, 6102

Country

Australia

Phone

+61 434645925

Fax

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	A randomized pilot study on self-management in head and neck lymphedema.	2020	https://dx.doi.org/10.1002/lio2.455

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically