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Trial registered on ANZCTR


Registration number
ACTRN12612000005853
Ethics application status
Approved
Date submitted
14/11/2011
Date registered
3/01/2012
Date last updated
9/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Lymphoedema Prevention Following Inguinal or Ilioinguinal Dissection for Metastatic Melanoma
Scientific title
Are compression garments and manual lymphatic drainage more effective than no compression or drainage in reducing the incidence/severity of lymphoedema in patients with metastatic melanoma (Stage III), following inguinal or ilioinguinal dissection?
Secondary ID [1] 273300 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoedema following inguinal or ilioinguinal groin dissection for metastatic melanoma 279073 0
Condition category
Condition code
Cancer 279261 279261 0 0
Malignant melanoma
Physical Medicine / Rehabilitation 279262 279262 0 0
Other physical medicine / rehabilitation
Cardiovascular 279361 279361 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thigh length, 20-30mmHg compression garments on the leg of the operative side, and medical grade compression shorts will be worn approximately 12 hours a day and removed for hygienne and sleeping. The specific garment utilised will depend on the individual patient measurements regarding best fit and fabric characteristics so may include garments from Sigvaris, Jobst, Juzo or if required, even be custom made. Unless medical co-morbidities dictate caution, all leg garments will be 20-30mmHg. All garments will be applied following removal of post operative drains.
Simple, or self lymphatic drainage (SLD) will be taught to participants in the intervention group by trained lymphoedema therapists. They will be provided an individual body map and drainage pathway and guidelines. They will receive three half hour formal 1:1 education sessions regarding self lymphatic drainage and are asked to conduct this each day for 6 months following post operative removal of drains. Training and education regarding correct garment donning and doffing of garments will occur at initial fitting with trained lymphoedema therapists ensuring that the participant (or carer) are able to correctly and safely apply and remove the garments. Drainage techniques and garment wear will continue to be assessed and monitored throughout the 6 month intervention phase.
Intervention code [1] 283648 0
Prevention
Intervention code [2] 283720 0
Treatment: Devices
Intervention code [3] 283721 0
Treatment: Other
Comparator / control treatment
Control group participants will be monitored via 3 monthly assessment (bioimpedence, circumferential and quality of life). If signs of lymphoedema arise, they will be offered comprehensive lymphoedema treatment. This is standard treatment.
Control group
Active

Outcomes
Primary outcome [1] 279883 0
Reduction in the rate of lymphoedema of 45% to 18% with statistical significance of p = 0.05. Allowing for a 33% two year mortality and 10% attrition a total of 155 participants need to be recruited to the study in order to achieve a sample of size of 88.
There is no worldwide consensus regarding quanitification of lymphoedema and this creates problems for classifying lymphoedema.
For the purpose of this study, our team have defined lymphoedema as a volume change of greater than 10% compared to the unaffected limb in addition to a bioimpedance change of 10 points from pre-operative baseline. The International Society of Lymphology defines "mild" lymphoedema as less than a 20% volume change.
Circumferential tape measurements at 10cm intervals (using a measuring board) will be taken of the operated side and contralateral leg. In addition, bioimpedence analysis will also be taken.
Quality of Life self rating scales (EORTC and the LYMQOL-leg) will also be utilised.
Assessments will be conducted by a blinded assessor pre-operatively, at 6 weeks post operatively and then at 3 monthly intervals for 2 years following surgery.
Timepoint [1] 279883 0
At two years after randomisation
Secondary outcome [1] 294673 0
Reduction in severity of lymphoedema between groups.

This will be quantified by the volume of lymphoedema measured using both circumferential measures to calculate volume and using bioimpedence measures.

LYMQOL-leg is a self-rating questionaire asking patients to quantify their perception of how lymphoedema is impacting on their life and function.
Timepoint [1] 294673 0
At two years after randomisation
Secondary outcome [2] 294841 0
Assess quality of life for all patients.

EORTC and the LYMQOL (leg) will be administered to control and intervention groups to assess quality of life.
Timepoint [2] 294841 0
At two years after randomisation
Secondary outcome [3] 294843 0
Assessing the impact of the following in development of lymphoedema (seroma, wound complications, co-morbidities, BMI, adjuvant radiotherapy).


Whilst evidence exists to support that increased BMI and radiotherapy may negatively impact on development of lymphoedema, we wish to analyse whether the number of pre-existing co-morbidities OR wound complications further contribue to lymphoedema development.
Timepoint [3] 294843 0
At two years after randomisation

Eligibility
Key inclusion criteria
Aged 18 years and over
English speaking (or interpreter available)
Ability to provide informed consent
Ability to attend regular followup
Confirmed metastatic melanoma
Ability to apply and remove garment, conduct simple lymphatic drainage (or carer available to do so)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Peripheral arterial disease (ABPI <.6)
Pre-existing lymphoedema
Bilateral groin dissection
Previous contralateral groin dissection

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)
Concealed allocation by sealed envelopes.

Eligible participants will be identified by research nurse at time of booking for surgery in both public and private consulting rooms. Interested and eligible participants will be provided with written information and offered to sign consent to be recruited into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised control trial via Mater Reseach Support Centre randomisation generated envelopes.
Computer generated randomised variable permuted block concealed allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Any participant on the control arm of the study who develops lymphoedema will be offered intervention and may therefore there may be some participants will crossover from control to intervention.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Baseline demographic characteristics of the control and intervention gorups will be reported; continuous variables using mean and standard deviation (SD) or median and interquartile range (IQR), depedent on whether the variable is normally distributed, as assessed by the Shapiro-Wilk test and the visual confirmation using histograms) and the frequencies and proportions for categorical variables. Primary outcome will be compared between the two groups using the difference of proportions, and will be presented as the absolute difference, corresponding 95% confidence interval (CI) and p-value; an intention to treat analysis will be used. Continuous secondary outcome measures will be assessed for differences between the control and intervention groups by reporting the mean (SD) or median (IQR) and associated 95% CI's; categorical secondary outcome measures will be treated similar to the priamry outcome. As the study is not powered to detect differences in the secondary outcome measures p-values will not be presented. To determine if there are factors that affect development of lymphoedema multivariate logistic regresssion will be undertaken including possible independent predictors (such as BMI, medical complications) that were identified as significant through bivariate analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
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)
QLD

Funding & Sponsors
Funding source category [1] 284130 0
Commercial sector/Industry
Name [1] 284130 0
Suncorp
Address [1] 284130 0
Suncorp Centre, Level 18,
36 Wickham Tce BRISBANE, QLD, 4000.
Country [1] 284130 0
Australia
Primary sponsor type
Hospital
Name
Mater Health Services
Address
Raymond Terrace
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 269091 0
Individual
Name [1] 269091 0
Melody Brown
Address [1] 269091 0
Mater Adult Hospital
Occupational Therapy Dept
Raymond Terrace
South Brisbane
Queensland 4101
Country [1] 269091 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272089 0
Mater Health Services Human Research Ethics Committee (EC00332)
Ethics committee address [1] 272089 0
Mater Adult Hospital
Raymond Terrace
South Brisbane, Queensland 4101
Ethics committee country [1] 272089 0
Australia
Date submitted for ethics approval [1] 272089 0
07/11/2011
Approval date [1] 272089 0
17/07/2012
Ethics approval number [1] 272089 0
Mater Health Services - HREC approval number 1885A

Summary
Brief summary
This study aims to determine whether compression garments and self massage can prevent or reduce lymphoedema (fluid retention) following groin dissection for metaststic melanoma.

Who is it for?
You may be eligible to join this study if you are a male or female aged 18 years and over with confirmed metastatic melanoma. You should be able to attend regular follow-up appointments over a period of 2 years.

Trial details.
Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will wear compression stockings 12 hours a day for 6 months and conduct daily self massage for a period of 6 months following post operative removal of drains. Participants in this group will receive 1:1 training in self massage over 3 half hour sessions. They will also receive education and training to ensure they (or their carer) are able to safely put on and remove the compression garment.
Participants in the other group will be monitored via 3 monthly assessments. If lymphoedema arises, they will be offered comprehensive treatment (as is standard treatment).
All participants will be assessed every 3 months to determine the incidence/severity of lymphoedema and quality of life, and whether this differs between groups.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33334 0
Mrs Melody Brown
Address 33334 0
Mater Adult Hosptial
Occupational Therapy Department
Raymond Terrace
South Brisbane
Queensland Australia 4101
Country 33334 0
Australia
Phone 33334 0
+61 7 31636000 pager 4312
Fax 33334 0
Email 33334 0
melody.brown@mater.org.au
Contact person for public queries
Name 16581 0
Mrs Melody Brown
Address 16581 0
Occupational Therapy Dept
Mater Adult Hospital
Level 2
Raymond Tce
South Brisbane, Queensland 4101
Country 16581 0
Australia
Phone 16581 0
+61 7 3163 6000 pager 4312
Fax 16581 0
Email 16581 0
melody.brown@mater.org.au
Contact person for scientific queries
Name 7509 0
Dr Dr Chris Allan
Address 7509 0
Mater Adult Hospital Raymond Terrace South Brisbane
Queensland Australia 4101
Country 7509 0
Australia
Phone 7509 0
+61 7 31638111
Fax 7509 0
Email 7509 0
c.allan@uq.edu.au

No data has been provided for results reporting
Summary results
Not applicable