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Trial registered on ANZCTR


Registration number
ACTRN12614000873628
Ethics application status
Approved
Date submitted
5/08/2014
Date registered
14/08/2014
Date last updated
1/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial of omega-3 fatty acid supplements to prevent skin cancer in lung transplant recipients
Scientific title
A pilot randomised controlled trial of omega-3 fatty acid supplements to prevent skin cancer in lung transplant recipients
Secondary ID [1] 285078 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
O3 Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 292606 0
Lung Transplant 292724 0
Condition category
Condition code
Respiratory 292919 292919 0 0
Other respiratory disorders / diseases
Cancer 292921 292921 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot trial of a double-blind, placebo-controlled, randomized study with 2 arms.
Arm1: Participants will receive 4 x 1000mg oral capsule of omega-3-acid ethyl esters 90, a fish oil supplement (Active) taken daily for 12 month
Arm 2: Participants will receive 4 x 1000mg capsules of olive oil (Placebo) taken daily for 12 months.
Any unused capsules will be returned to study Doctors on follow up visits.
Intervention code [1] 289916 0
Prevention
Comparator / control treatment
Placebo oral capsule of 4 x 1000mg Olive Oil.
Control group
Placebo

Outcomes
Primary outcome [1] 292784 0
The primary objective of this study is to assess the feasibility of evaluating oral consumption of 4g (4 x 1000mg capsules) fish oil supplements daily to prevent Actinic keratoses (AK) and skin cancers in high-risk lung transplant patients.
Assessed by reviewing Histology reports and observed number of Basal cell carcinoma (BCC) and Squamous cell carcinoma (SCC) as an indication of sufficient power for a definitive trial.
Timepoint [1] 292784 0
SCC and BCC counts at baseline and 52 weeks. Histology reports reviewed from baseline to week 60.
Primary outcome [2] 292882 0
The primary objective of this study is to assess the acceptability of evaluating oral consumption of 4g (4 x 1000mg capsules) fish oil supplements daily to prevent Actinic keratoses (AK) and skin cancers in high-risk lung transplant patients.
Assessed by compliance with the intervention (3-monthly capsule counts) drop-out rate of lung transplant participants, and adverse events
Timepoint [2] 292882 0
Baseline capsules count at visit week 1. 3 Monthly capsule counts at visit weeks 18, 34, 52. A blood sample is taken for fatty acid profiling week one and week 52. Dropout rates at study end week 60. Assessment of Adverse events Phone call week 4 week 56 and week 60, in person visit Week 18, 34, 52.
Secondary outcome [1] 309672 0
Comparison of whole-body Actinic keratoses prevalence at baseline verse 12 month in the two treatment groups as assessed on dermatological examination.
Timepoint [1] 309672 0
Skin Exam and Health & Sun, Dietary and Dietary Supplement Questionnaire at baseline visit week 1 and week 52
Secondary outcome [2] 309673 0
Comparison of total counts of new Skin Cancer after 12 months in intervention group verse controls and by specified subgroups (actinic skin tumour history and systemic retinoid therapy (yes, no).
Timepoint [2] 309673 0
Skin Exam and Health & Sun, Dietary and Dietary Supplement Questionnaire at baseline visit week 1 and week 52
Secondary outcome [3] 309674 0
Comparison of BCC and SCC counts separately after 12 months in intervention group verse controls.
Timepoint [3] 309674 0
Skin Exam and Health & Sun, Dietary and Dietary Supplement Questionnaire at baseline visit week 1 and week 52
Secondary outcome [4] 309675 0
Comparison of baseline and 12-month red blood cell n3/n6 PUFA levels in the two treatment groups by specified subgroups by actinic skin tumour history and systemic retinoid therapy (yes, no).
Timepoint [4] 309675 0
A blood sample is taken for fatty acid profiling week one and week 52.

Eligibility
Key inclusion criteria
1. Male and female lung transplant recipients Greater than or equal to 18 years of age.
2. Greater than or equal to 1 year post lung transplant.
3. Use of systemic retinoid therapy permitted if on stable dosing for previous 3 months.
4. Will be able to attend the clinic for at least Visit 1 and Visit 4 within the recruitment timeframe.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to give informed consent.
2. Have innately black or dark brown skin.
3. Have a fish allergy.
4. Have a soya allergy.
5. Unable to take gelatin.
6. Have a bleeding disorder or bleeding episode in last 3 months
7. Are receiving warfarin, heparin or low molecular weight heparin in therapeutic doses. (Patients receiving heparin or low molecular weight heparin in prophylactic doses will not be excluded)
8. Are already taking fish oil supplements and unwilling to discontinue for 2 months before randomisation and for trial period.
9. Pregnant

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)
Existing clinical records from the Lung Transplant Database will be screened to identify potentially eligible participants according to inclusion and exclusion criteria for this study.
Potentially eligible participants will be approached first by email or postal letter providing information about this trial, once consent is signed participants will be allocated a unique ID that will be randomised to receive either placebo or fish oil.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
*Randomisation tables and allocation schedules provided by study statistician, generated using statistical software (StatsDirect)
*Strata to history of previous lesion/s
*Anticipate 20-30 percent of participants with some history of skin cancer. Allowed up to 100 with no history and 60 with history.
*Trial nurse/project officer confirms eligibility of consenting participant
-Participant details are recorded on the relevant allocation schedule according to skin cancer history status
-Patient ID and allocation code are written on a script by the trial clinician
-Study nurse takes the script to pharmacy
-Pharmacist matches allocation code to placebo/intervention using unblinded tables provided by trial statistician
-Bottles containing study drug, labelled with patient ID and allocation code, and handed back to the study nurse for dispensing to the participant
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study in N equals 100 participants (50 per group) is a pilot trial and is not designed to assess difference between treatment groups. The sample size is based on the total expected number of eligible and consenting lung transplant patients at The Prince Charles Hospital. It will allow estimation of consent, adherence and retention rates to within approximately 10 percentage points with 95percent confidence.

Primary analyses will be descriptive in line with the pilot aims to estimate parameters required to design a definitive study. Eligibility, consent, adherence and retention proportions will be calculated overall and the latter two will be assessed by allocation arm.

Secondary analyses to compare the groups will be performed using logistic and linear regression as appropriate for the specified secondary outcomes using a complete case approach under the intention to treat principle. No imputation will be undertaken. All analyses will be adjusted for the stratification criteria used in the randomisation schedule and for baseline values of the secondary outcome where available.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/09/2014
Actual
15/12/2014
Date of last participant enrolment
Anticipated
18/03/2015
Actual
26/02/2015
Date of last data collection
Anticipated
Actual
17/06/2016
Sample size
Target
100
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2794 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 289711 0
Commercial sector/Industry
Name [1] 289711 0
Westpac Bicentennial Foundation
Country [1] 289711 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
QIMR Berghofer Medical Research Institute
Address
300 Herston Road, Herston, Brisbane, QLD 4006
Country
Australia
Secondary sponsor category [1] 288377 0
None
Name [1] 288377 0
Address [1] 288377 0
Country [1] 288377 0
Other collaborator category [1] 278073 0
Hospital
Name [1] 278073 0
The Prince Charles Hospital
Address [1] 278073 0
627 Rode Rd, Chermside, QLD 4032
Country [1] 278073 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291422 0
QIMR Berghofer Medical Research Institute HREC
Ethics committee address [1] 291422 0
300 Herston Road, Herston, Brisbane QLD 4006
Ethics committee country [1] 291422 0
Australia
Date submitted for ethics approval [1] 291422 0
17/07/2014
Approval date [1] 291422 0
Ethics approval number [1] 291422 0
P2022
Ethics committee name [2] 291423 0
The Prince Charles Hospital, Metro North Hospital and Health Service Human Research Ethics Committee (HREC)
Ethics committee address [2] 291423 0
Lower Ground Floor
Administration Building
The Prince Charles Hospital
Rode Road
Chermside Qld 4032
Ethics committee country [2] 291423 0
Australia
Date submitted for ethics approval [2] 291423 0
24/07/2014
Approval date [2] 291423 0
06/08/2014
Ethics approval number [2] 291423 0
HREC/14/QPCH/115

Summary
Brief summary
This study aims to evaluate the effectiveness of fish oil for the prevention of skin cancer in lung transplant recipients.

Who is it for?
You may be eligible to join the study if you are over 18 years of age, and are a lung transplant recipient for at least 1 year.

Study details

Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will take 4 x 1000mg oral capsule of omega-3 fish oil supplement daily for 12 months. Participants in the other group will take 4 x 1000mg of placebo (olive oil) daily for 12 months. Participants will not know which treatment they are taking until the end of the study.
All participants will be asked to complete questionnaires, blood tests and skin exams at baseline and at the end of the study at 12 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50306 0
Prof Adele Green
Address 50306 0
QIMR Berghofer Medical Research Institute
300 Herston Road
Herston
Brisbane
QLD
4006
Country 50306 0
Australia
Phone 50306 0
+61 7 3362 0234
Fax 50306 0
+61 7 3845 3503
Email 50306 0
adele.green@qimrberghofer.edu.au
Contact person for public queries
Name 50307 0
Ms Lisa Ferguson
Address 50307 0
QIMR Berghofer Medical Research Institute
300 Herston Rd, Herston QLD 4006
Country 50307 0
Australia
Phone 50307 0
+61 7 3362 0256
Fax 50307 0
Email 50307 0
lisa.ferguson@qimrberghofer.edu.au
Contact person for scientific queries
Name 50308 0
Prof Adele Green
Address 50308 0
QIMR Berghofer Medical Research Institute
300 Herston Road
Herston
Brisbane
QLD
4006
Country 50308 0
Australia
Phone 50308 0
+61 7 3362 0234
Fax 50308 0
+61 7 3845 3503
Email 50308 0
adele.green@qimrberghofer.edu.au

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

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