Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000255482
Ethics application status
Approved
Date submitted
16/06/2015
Date registered
24/02/2016
Date last updated
24/04/2019
Date data sharing statement initially provided
24/04/2019
Date results provided
24/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does subcutaneous needle drainage of lymphoedema in patients with advanced malignancy have an effect on the patient's quality of life?
Scientific title
Quantitative Study of Subcutaneous Needle Drainage of Lymphoedema in Advanced Malignancy: Evaluating the Effect on Quality of Life.
Secondary ID [1] 286734 0
NIL
Universal Trial Number (UTN)
U1111-116-4348
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoedema 295096 0
Cancer 295401 0
Condition category
Condition code
Cardiovascular 295342 295342 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cancer 297935 297935 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Needles inserted into lower limbs under sterile technique. Usually two needles in each affected limb according to where the lymphoedema is causing the most problems ie. if scrotal we place the needles higher on the leg. The palliative medicine specialist inserts the needles into the subcutaneous layer according to the protocol. The average duration of drainage is 5 days as an inpatient, and the needles stay in the entire time unless drainage stops or it becomes uncomfortable. The maximum duration for the needles remaining in situ is 6 days. The average length of the drainage was determined by the pilot study.
Intervention code [1] 292108 0
Treatment: Other
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295323 0
Quality of life using the LYMQOL - LEG tool

Mobility Measures tool adapted from ACC. This is the name of the tool.
These two make up a composite primary outcome.
Timepoint [1] 295323 0
Before the needle drainage commences, 1-2 days after needles removed and 12-14 days after needles removed.
Secondary outcome [1] 315359 0
Complication rates including infection and renal failure
The cellulitis is measured using a Cellultitis Grading Scale (self- developed based on pilot data) and the renal failure is measured using blood tests
Timepoint [1] 315359 0
Up to three weeks after the procedure
Secondary outcome [2] 315436 0
Palliative Performance Status using Palliative Performance Scale PPSv2
Timepoint [2] 315436 0
At beginning of study

Eligibility
Key inclusion criteria
Patients must have advanced malignancy and be suitable for palliative care.

Patients must have lymphoedema suitable for lymphoedema drainage, i.e.:
Lymphoedema is causing significant distress to patient, and contributing to a loss in their quality of life
Lymphoedema no longer able to be controlled by use of compression stockings, massage or bandaging
There is evidence of blockage in lymphatic flow proximal to the affected limb ( ie: fluid cannot be drained through normal flow pathways)
Lymphoedema is soft and pitting (as opposed to hard, fibrotic and non pitting)

Age >18 years.

Ability to understand and the willingness to sign or verbally consent to a written or verbal informed consent document.

Patients must speak English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have had chemotherapy within the last 30 days

Patients with neutropenia (<1x10(9)L) and/or thrombocytopenia (<50x10(9)L)

Patients who have active cellulitis

Patients who are acutely unwell

Patients who are immunosuppressed, anti-coagulated or have unexplained fever must be evaluated by medical professional before procedure

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)
Patients with advanced malignancy and lower limb oedema are identified by appropriate health professionals and offered the procedure. There is no randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2015
Actual
20/08/2015
Date of last participant enrolment
Anticipated
Actual
11/08/2017
Date of last data collection
Anticipated
Actual
25/08/2017
Sample size
Target
40
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 6904 0
New Zealand
State/province [1] 6904 0

Funding & Sponsors
Funding source category [1] 291346 0
Charities/Societies/Foundations
Name [1] 291346 0
Genesis Oncology Trust
Country [1] 291346 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
New Zealand Institute of Community Health Care
Address
15 Mansfield Avenue
P O Box 36126
Merivale
Christchurch 8146
Country
New Zealand
Secondary sponsor category [1] 290157 0
None
Name [1] 290157 0
Address [1] 290157 0
Country [1] 290157 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292907 0
Health and Disability Ethics Committee
Ethics committee address [1] 292907 0
Ethics committee country [1] 292907 0
New Zealand
Date submitted for ethics approval [1] 292907 0
Approval date [1] 292907 0
13/05/2015
Ethics approval number [1] 292907 0
15/STH/28

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

Contacts
Principal investigator
Name 57342 0
Dr Amanda Landers
Address 57342 0
Nurse Maude
P O Box 36-126
Merivale
Christchurch 8146
Country 57342 0
New Zealand
Phone 57342 0
+64 3 3754274
Fax 57342 0
Email 57342 0
[email protected]
Contact person for public queries
Name 57343 0
Amanda Landers
Address 57343 0
Nurse Maude
P O Box 36-126
Merivale
Christchurch 8146
Country 57343 0
New Zealand
Phone 57343 0
+64 3 3754274
Fax 57343 0
Email 57343 0
[email protected]
Contact person for scientific queries
Name 57344 0
Amanda Landers
Address 57344 0
Nurse Maude
P O Box 36-126
Merivale
Christchurch 8146
Country 57344 0
New Zealand
Phone 57344 0
+64 3 3754274
Fax 57344 0
Email 57344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not necessary


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.