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Trial registered on ANZCTR


Registration number
ACTRN12624000939594
Ethics application status
Approved
Date submitted
22/04/2024
Date registered
2/08/2024
Date last updated
2/08/2024
Date data sharing statement initially provided
2/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Niagara® Cycloid® action on legs with chronic oedema/lymphoedema following treatment for cancer in patients aged 45 to 75.
Scientific title
The effect of Niagara® Cycloid® action on legs with chronic oedema/lymphoedema following treatment for cancer.
Secondary ID [1] 311094 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic oedema 332848 0
Ovarian Cancer 334252 0
Prostate Cancer 334253 0
Chronic Lymphoedema 334341 0
Condition category
Condition code
Inflammatory and Immune System 329564 329564 0 0
Other inflammatory or immune system disorders
Cancer 330917 330917 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 330918 330918 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 330919 330919 0 0
Ovarian and primary peritoneal
Cancer 330920 330920 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Only patients enrolled in the study will receive access to the massage pad. All participants must use the massage pad according to a defined regimen, as outlined below.
1.Pad on abdominal area (or lower back) – Patient lying face up.
2.Pad under posterior thighs – Patient lying face up.
3.Pad on top of anterior thigh – Patient lying face up.
4.Pad under lower leg (ankle to calf area) – Patient lying face up.
This regimen was designed to simulate the sequence used during a lymphoedema drainage massage such as manual lymphatic drainage (although it is acknowledged that the exact nature cannot be mimicked). The aim being to clear lymph nodes and vessels in the abdomen and lower back before working downward and clearing vessels in the thighs and calves. Each placement period is 10 mins.
Other key information:
who will deliver the regimen: Participants under the supervision initially of the researchers to check they do it properly.
Only one procedure and that is delivery of massage using massage pad for a total of 30 mins.
The regimen will be delivered daily over 3 weeks.
The regimen will occur at the patients residence.
Strategies used to assess monitor adherence or fidelity to the defined regimen, include: Telephone or computer video checks (depending on what the participant has access to initially) and then diary.
Normal routine will continue in addition to the regime. That is skin care, manual lymphatic drainage, diaphragmatic breathing, compression.
Intervention code [1] 329033 0
Treatment: Devices
Comparator / control treatment
Control is current best practice i.e. the treatment they are currently using for their lymphoedema.
Normal routine: is skin care, manual lymphatic drainage, diaphragmatic breathing, compression. Control group receives their 'normal routine'.
Control group
Active

Outcomes
Primary outcome [1] 337357 0
changes in venous outflow
Timepoint [1] 337357 0
baseline and 3 weeks post-treatment starting.
Primary outcome [2] 338681 0
changes in limb fluid volumes
Timepoint [2] 338681 0
Baseline and 3 weeks post-treatment starting.
Primary outcome [3] 338682 0
changes in circumference - whole legs upper and lower parts with the ankle being the most distal measurement and groin the most proximal.
Timepoint [3] 338682 0
Baseline and 3 weeks post-treatment starting.
Secondary outcome [1] 431561 0
Quality of life
Timepoint [1] 431561 0
3 days, 1 week, 2 weeks and 3 weeks post-treatment starting as well as at 2 weeks and 4 weeks after the end of the trial
Secondary outcome [2] 437428 0
changes in arterial inflow (this is a primary outcome).
Timepoint [2] 437428 0
baseline and 3 weeks post-treatment starting.
Secondary outcome [3] 437429 0
Changes in limb fibrosis.
Timepoint [3] 437429 0
3 days, 1 week, 2 weeks and 3 weeks post-treatment starting as well as at 2 weeks and 4 weeks after the end of the trial.

Eligibility
Key inclusion criteria
Clinically diagnosed Chronic oedema/lymphoedema (arising from treatment for cancer) of one leg, more than 1.5 years duration but less than 10 years duration.
BMI classes: Overweight 25- 30 and Obese Class I (Moderately obese)31-35.
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No clinically diagnosed thyroid disorder (nor medications for it)
No venous issues of the legs including venous reflux, significant varicosities or signs of venous disorder/disease (LDS, Haemosiderin in over large areas) Spider veins and minor superficial venous telangiectasia ok)
No leg swelling prior to the intervention for cancer (statement from the referring clinician about this)
No medications likely to have an influence on sodium retention such as Beta blockers, Diuretics.
No current wounds/ulcers on the legs
No signs of significant recent soft tissue wounding
No signs of current skin breakdown.
Normal liver, renal and heart function
No Current or recent (< 1 month) bacterial infections (Cellulitis)

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315353 0
Commercial sector/Industry
Name [1] 315353 0
Niagara Australia Pty Ltd
Country [1] 315353 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Niagara Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 317413 0
None
Name [1] 317413 0
Address [1] 317413 0
Country [1] 317413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314272 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 314272 0
Ethics committee country [1] 314272 0
Australia
Date submitted for ethics approval [1] 314272 0
29/06/2020
Approval date [1] 314272 0
19/06/2024
Ethics approval number [1] 314272 0
90.24

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

Contacts
Principal investigator
Name 131010 0
Prof Neil Piller
Address 131010 0
Lymphoedema Clinical Research Unit Department of Surgery Level 3, Flinders Medical Centre Bedford Park, South Australia, 5042
Country 131010 0
Australia
Phone 131010 0
+61 421140971
Fax 131010 0
Email 131010 0
neil.piller@flinders.edu.au
Contact person for public queries
Name 131011 0
Kea Dent
Address 131011 0
KD&A Pty Ltd Level 3, Suite 301, 27 Belgrave Street Manly NSW 2095
Country 131011 0
Australia
Phone 131011 0
+61 411101392
Fax 131011 0
Email 131011 0
kdent@kdas.com.au
Contact person for scientific queries
Name 131012 0
Neil Piller
Address 131012 0
Lymphoedema Clinical Research Unit Department of Surgery Level 3, Flinders Medical Centre Bedford Park, South Australia, 5042
Country 131012 0
Australia
Phone 131012 0
+61 421140971
Fax 131012 0
Email 131012 0
neil.piller@flinders.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


What supporting documents are/will be available?




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.