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Trial registered on ANZCTR


Registration number
ACTRN12617001574336
Ethics application status
Approved
Date submitted
12/11/2017
Date registered
23/11/2017
Date last updated
23/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of negative pressure in the treatment of secondary arm lymphoedema and fibrosis in post-breast cancer patients
Scientific title
The use of negative pressure in the treatment of secondary arm lymphoedema and fibrosis in post-breast cancer patients
Secondary ID [1] 293294 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lymphoedema 305368 0
tissue fibrosis 305369 0
breast cancer 305517 0
Condition category
Condition code
Inflammatory and Immune System 304655 304655 0 0
Other inflammatory or immune system disorders
Cardiovascular 304656 304656 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cancer 304760 304760 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A hand held PhysioTouch unit which applies negative pressure will be used according to upper limb, local fibrosis and scar treatment guidelines outlined by PhysioTouch Australia and NZ. Its use may result in structural tissue changes leading to a decrease in the extent of lymphoedema associated fibrosis and scar tissue complications arising from the surgery or
radiotherapy.
Intervention will be delivered by two researchers trained in the use of PhysioTouch by a lymphoedema physiotherapist.
Participants will come into the lymphoedema clinical research unit at Flinders Centre for Innovation in Cancer individually and intervention will be delivered face-to-face for 20-30 minutes over 4 different sessions. The sessions will be run over 2 weeks with at least 48 hours between each session.



Intervention code [1] 299547 0
Treatment: Devices
Comparator / control treatment
Side (including arm and chest wall) unaffected by lymphoedema and/or tissue fibrosis. Both arms and all of chest wall will be treated.
Control group
Active

Outcomes
Primary outcome [1] 303874 0
Extent of fibrosis (assessed with indurometer, palpation) - researcher will score the extent of fibrosis expressing the visual and palpable extent of fibrotic abnormality and to the nearest 10% on a scale from 0 (no fibrosis) to 10 (100% fibrosis)
Timepoint [1] 303874 0
Measurements will be taken before, immediately after, and 1 hour after intervention. Data collection will be done over 4 visits, with at least 48 hours between each visit, within 2 weeks post commencement of intervention. Primary endpoint is at the end of the first visit 1 hour after the intervention.
Secondary outcome [1] 340327 0
fascial and scar glide (assessed by visual analogue scale (VAS))
- this is a composite secondary outcome
Timepoint [1] 340327 0
Measurements will be taken before, immediately after, and 1 hour after intervention. Data collection will be done over 4 visits, with at least 48 hours between each visit, within 2 weeks post commencement of intervention.
Secondary outcome [2] 340334 0
range of motion in shoulder joint (assessed by goniometer)
Timepoint [2] 340334 0
Measurements will be taken before and 1 hr after intervention. Data collection will be done over 4 visits, with at least 48 hours between each visit, within 2 weeks post commencement of intervention.
Secondary outcome [3] 340383 0
patient and therapist rating of parameters of scar tissue (assessed by POSAs questionnaire ver 2.0)
Timepoint [3] 340383 0
Measurements will be taken before, and 1 hour after intervention. Data collection will be done over 4 visits, with at least 48 hours between each visit, within 2 weeks post commencement of intervention.
Secondary outcome [4] 340384 0
perfusion to the area (assessed by FLIR systems model P660 infrared camera)
Timepoint [4] 340384 0
Measurements will be taken before, immediately after anterior chest is treated, immediately after posterior chest is treated, and immediately after intervention. Data collection will be done over 4 visits, with at least 48 hours between each visit, within 2 weeks post commencement of intervention.
Secondary outcome [5] 340385 0
change in arm volume (assessed by perometry)
Timepoint [5] 340385 0
Measurements will be taken before, immediately after, and 1 hour after intervention. Data collection will be done over 4 visits, with at least 48 hours between each visit, within 2 weeks post commencement of intervention.
Secondary outcome [6] 340386 0
changes in arm fluid levels (assessed by SFB7 bioimpedance (U400))
Timepoint [6] 340386 0
Measurements will be taken before intervention only at the start of each session. Data collection will be done over 4 visits, with at least 48 hours between each visit, within 2 weeks post commencement of intervention.
Secondary outcome [7] 340387 0
magnitude of pressure exerted by bra on chest (assessed by Kikuhime sub-bandage pressure monitor)
Timepoint [7] 340387 0
Measurements will be taken before, immediately after, and 1 hour after intervention. Data collection will be done over 4 visits, with at least 48 hours between each visit, within 2 weeks post commencement of intervention.
Secondary outcome [8] 340388 0
changes in local tissue water (assessed by moisture meter)
Timepoint [8] 340388 0
Measurements will be taken before, immediately after, and 1 hour after intervention. Data collection will be done over 4 visits, with at least 48 hours between each visit, within 2 weeks post commencement of intervention.
Secondary outcome [9] 340634 0
patient and therapist rating of parameters of tissue fibrosis (assessed by POSAs questionnaire ver 2.0)
Timepoint [9] 340634 0
Measurements will be taken before, and 1 hour after intervention. Data collection will be done over 4 visits, with at least 48 hours between each visit, within 2 weeks post commencement of intervention.

Eligibility
Key inclusion criteria
- Unilateral arm lymphoedema following breast cancer with no preexisting
risks or surgery on the other side
OR
- Chest wall scar tissue and/or fibrosis following breast cancer with no preexisting risks

AND
- Stage 2 arm lymphoedema in a female following treatment for breast cancer
- Must be 6 months postsurgery, chemotherapy and or radiation treatment for breast cancer
- Age over 18 years old
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of active or recurrent cancer, or less than 6 months at the time of initial evaluation from completion of chemotherapy, radiation therapy or primary surgery for the
treatment of cancer.
- Diagnosis or suspected acute infection
- Individuals with pacemaker or other implanted electronic devices
- Diagnosis of acute thrombophlebitis (in last 2 months)
- Receiving corticosteroids or immune suppressants
- Presence of open wound or any skin inflammation, irritation of skin allergies
- Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
- Diagnosis of pulmonary oedema
- Diagnosis of congestive heart failure
- Pregnancy
- Any condition where increased venous or lymphatic return is undesirable
- Inability or unwillingness to participate in all aspects of study protocol and or inability to provide informed consent
- Currently participating in another clinical trial

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



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Data analysis will be completed by a qualified statistician using the statistical analysis
software R version 3.4.1. In comparing of the effect of the negative pressure device on
lymphoedema and fibrosis, a 95% Confidence Interval (CI) and a p value <0.05 will be
sufficient to reject the null hypothesis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/11/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 297917 0
University
Name [1] 297917 0
Flinders University
Country [1] 297917 0
Australia
Primary sponsor type
Individual
Name
Neil Piller
Address
Level 3, Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 296979 0
None
Name [1] 296979 0
Address [1] 296979 0
Country [1] 296979 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298967 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 298967 0
Flinders Medical Centre
Ward 6C, Room 6A219
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 298967 0
Australia
Date submitted for ethics approval [1] 298967 0
26/07/2017
Approval date [1] 298967 0
06/11/2017
Ethics approval number [1] 298967 0
HREC/17/SAC/294

Summary
Brief summary
The main aim of this study is to assess the use of Physiotouch in treating secondary arm lymphoedema and tissue fibrosis in patients who have undergone
unilateral surgical treatment for breast cancer.

Participants will be females who have had breast cancer and have undergone unilateral mastectomy. Key exclusion criteria woman who: has received breast-cancer related treatment within the last 6 months, is pregnant, younger than age 18, have implantable devices, have heart problems, have a tendency to clot, or are predisposed to infection.

Study details:
Participants will not need to change any current conservative therapy they are receiving for their lymphoedema or tissue fibrosis. The PhysioTouch device will be use to administer treatment by professionals trained in the use of this device. All participants will be receiving the same treatment.

This study will assess the possibility of Physiotouch, and negative pressure, being used as an alternative therapy to the current conservative management for lymphoedema and tissue fibrosis which only uses positive pressure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78826 0
Prof Neil Piller
Address 78826 0
Level 3, Flinders Medical Centre
Flinders Drive
Bedford Park SA, 5042
Country 78826 0
Australia
Phone 78826 0
+61 8 82044711
Fax 78826 0
Email 78826 0
[email protected]
Contact person for public queries
Name 78827 0
Kathleen Ly
Address 78827 0
Flinders Centre for Innovation in Cancer, Level 4
Flinders Drive
Bedford Park SA 5042
Country 78827 0
Australia
Phone 78827 0
+61 404314164
Fax 78827 0
Email 78827 0
[email protected]
Contact person for scientific queries
Name 78828 0
Frederick Gott
Address 78828 0
Flinders Centre for Innovation in Cancer, Level 4
Flinders Drive
Bedford Park SA 5042
Country 78828 0
Australia
Phone 78828 0
+61 459498155
Fax 78828 0
Email 78828 0
[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
No additional documents have been identified.