Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000639820
Ethics application status
Approved
Date submitted
14/06/2012
Date registered
15/06/2012
Date last updated
18/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention of breast cancer-related lymphoedema following axillary lymph node clearance
Scientific title
Investigation of the use of manual lymphatic drainage in addition to skin care, compression garments and exercise in the prevention of breast cancer related lymphoedema in patients who have had axillary node clearance for breast cancer.
Secondary ID [1] 280670 0
Nil
Universal Trial Number (UTN)
U1111-1131-8203
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 286690 0
Lymphoedema 286691 0
Condition category
Condition code
Cancer 286990 286990 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manual lymphatic drainage, performed initially by lymphoedema-trained physiotherapists who will also instruct patients how to perform manual lymphatic drainage, to be done on a daily basis, for less than one hour for six weeks postoperatively. Manual lymphatic drainage is a specialised form of massage designed to assist drainage of the excess lymph fluid from the upper chest and arm. It is a very light skin massage (as opposed to deep tissue/sports-type massage) and hence can be performed by a trained physiotherapist but also by patients themselves.
Intervention code [1] 285076 0
Prevention
Intervention code [2] 285082 0
Treatment: Other
Comparator / control treatment
Control group: Breast cancer patients undergoing axillary lymph node clearance receiving current standard best practice (skin care, compression garments and exercise)
Control group
Active

Outcomes
Primary outcome [1] 287326 0
Limb volume, calculated assuming the arm is a cylinder of varying radius on the basis of arm circumference measurements starting at 20cm proximal to the cuticle of the middle finger and at 4cm intervals proximal to that.
Timepoint [1] 287326 0
3-4 months after the end of the intervention, then 6, 12, 18, 24 & 36 months
Secondary outcome [1] 297913 0
Validation of the use of bio-impedance technology (QuadScan 4000) to calculate the presence of lymphoedema against standard validated limb volume measurements.
Timepoint [1] 297913 0
3-4 months after the end of the intervention, then 6, 12, 18, 24 & 36 months

Eligibility
Key inclusion criteria
Patients undergoing axillary lymph node clearance for primary operable breast cancer
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recurrent breast cancer
Previous axillary surgery
Previous axillary radiotherapy
Previous axillary/arm pathology leading to arm volume changes

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are identified at the time of decision to treat, given verbal and written information and offered opportunity to discuss the trial. Inclusion is on an "opt-in" basis and is voluntary with no penalty for non-participation.
Treatment allocation is by computer-based randomisation with sealed envelopes prepared in advance, the study is not blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is performed by the random permuted blocks method.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
178
Accrual to date
Final
Recruitment outside Australia
Country [1] 4361 0
United Kingdom
State/province [1] 4361 0

Funding & Sponsors
Funding source category [1] 285436 0
Hospital
Name [1] 285436 0
Norfolk & Norwich University Hospital
Country [1] 285436 0
United Kingdom
Primary sponsor type
Hospital
Name
Norfolk & Norwich University Hospital
Address
Colney Lane
Norwich
Norfolk
NR4 7UY
United Kingdom
Country
United Kingdom
Secondary sponsor category [1] 284287 0
None
Name [1] 284287 0
Address [1] 284287 0
Country [1] 284287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287445 0
Norfolk Research Ethics Committee
Ethics committee address [1] 287445 0
Ethics committee country [1] 287445 0
United Kingdom
Date submitted for ethics approval [1] 287445 0
Approval date [1] 287445 0
01/02/2011
Ethics approval number [1] 287445 0
10/H0310/51

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

Contacts
Principal investigator
Name 34309 0
Address 34309 0
Country 34309 0
Phone 34309 0
Fax 34309 0
Email 34309 0
Contact person for public queries
Name 17556 0
Simon Pain
Address 17556 0
Norfolk & Norwich University Hospital
Colney Lane
Norwich
Norfolk
NR4 7UY
United Kingdom
Country 17556 0
United Kingdom
Phone 17556 0
44 (0)1603286430
Fax 17556 0
Email 17556 0
[email protected]
Contact person for scientific queries
Name 8484 0
Simon Pain
Address 8484 0
Norfolk & Norwich University Hospital
Colney Lane
Norwich
Norfolk
NR4 7UY
United Kingdom
Country 8484 0
United Kingdom
Phone 8484 0
44 (0)1603286430
Fax 8484 0
Email 8484 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.