Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000086066
Ethics application status
Approved
Date submitted
21/01/2010
Date registered
27/01/2010
Date last updated
24/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nambour Community-based Skin Cancer Prevention Trial
Scientific title
Community-based trial of daily versus usual sunscreen use and beta-carotene versus placebo supplements to prevent skin cancer
Secondary ID [1] 284629 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
basal cell carcinoma 256483 0
squamous cell carcinoma of the skin 256484 0
solar keratoses 256485 0
photoageing 256486 0
cutaneous melanoma 256487 0
blood lipids as assessed by fasting blood tests 291946 0
Condition category
Condition code
Skin 256653 256653 0 0
Dermatological conditions
Cancer 256654 256654 0 0
Non melanoma skin cancer
Public Health 256655 256655 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Daily sunscreen, Beta-carotene supplements"
Daily sunscreen: (Sun Protection Factor (SPF) 15+, to be applied to head, neck, arms and hands every morning (and to reapply after heavy sweating, bathing, or long sun exposure), for 5 years.

Beta-carotene supplements: 30mg once daily as oral capsule, for 5 years.

4 arms in trial viz. Arm 1: daily sunscreen, beta-carotene supplements Arm 2: daily sunscreen, placebo supplements Arm 3: beta-carotene supplements, discretionary sunscreen Arm 4: discretionary sunscreen, placebo supplements
Intervention code [1] 255771 0
Prevention
Comparator / control treatment
"discretionary sunscreen, placebo supplements"
Discretionary sunscreen for 5 years.
Placebo: microcellulose pills, once daily, orally, for 5 years
Control group
Placebo

Outcomes
Primary outcome [1] 257549 0
basal cell carcinoma (BCC) incidence: ascertained by clinical examination and medical records; histologically-confirmed
Timepoint [1] 257549 0
5 years after randomisation; 8 years after cessation of trial (or 13 years after randomisation)
Primary outcome [2] 257550 0
squamous cell carcinoma (SCC) incidence: ascertained by clinical examination and medical records; histologically-confirmed
Timepoint [2] 257550 0
5 years after randomisation; 8 years after cessation of trial (or 13 years after randomisation)
Primary outcome [3] 257551 0
solar keratosis (SK) prevalence: SK clinically diagnosed by dermatologists
Timepoint [3] 257551 0
5 years after randomisation
Primary outcome [4] 257552 0
photogeing severity: assessed clinically and by microtopography using silicon casts of the back of the hand
Timepoint [4] 257552 0
5 years after randomisation; 10 years after cessation of trial (or 15 years after randomisation)
Secondary outcome [1] 262794 0
melanoma incidence: melanomas ascertained through medical records and cancer registry; histologically-confirmed and reviewed
Timepoint [1] 262794 0
10 years after cessation of trial (or 15 years after randomisation)
Secondary outcome [2] 308345 0
blood lipids as assessed fasting blood test
Timepoint [2] 308345 0
at baseline for a random sample and at 5 years (end of trial) for majority of trial participants

Eligibility
Key inclusion criteria
Registered on the state electoral roll for Nambour in Nov 1986
Minimum age
18 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lack of signed consent

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)
Enrolled by acceptance of letter of invitation. Allocation by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
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
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/1992
Actual
1/02/1992
Date of last participant enrolment
Anticipated
Actual
15/03/1992
Date of last data collection
Anticipated
Actual
31/12/2015
Sample size
Target
1850
Accrual to date
Final
1625
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 256257 0
Government body
Name [1] 256257 0
National Health and Medical Research Council of Australia (NHMRC)
Country [1] 256257 0
Australia
Primary sponsor type
Individual
Name
Prof Adele Green
Address
QIMR Berghofer Institute of Medical Research
300 Herston Road, Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 251587 0
None
Name [1] 251587 0
Address [1] 251587 0
Country [1] 251587 0
Other collaborator category [1] 1019 0
Individual
Name [1] 1019 0
Gail Williams
Address [1] 1019 0
School of Population Health
University of Queensland
Herston Road
Herston
QLD 4006
Country [1] 1019 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258349 0
QIMR Human Research Ethics Committee
Ethics committee address [1] 258349 0
Queensland Institute of Medical Research
PO Royal Brisbane Hospital
Queensland 4029,
Ethics committee country [1] 258349 0
Australia
Date submitted for ethics approval [1] 258349 0
Approval date [1] 258349 0
12/06/1991
Ethics approval number [1] 258349 0
18/91

Summary
Brief summary
A randomised trial was conducted to assess whether daily application of a sun protection factor (SPF) 15+ sunscreen to the head, neck, arms and hands, or beta-carotene supplementation (30 mg/day) would prevent skin cancers and related tumours and premature skin ageing in comparison with discretionary use of sunscreen or a daily placebo supplement. The The hypothesis was that regular sunscreen use by adult Caucasians prevents the occurrence of skin cancers and related sun-related degenerative skin conditions
Trial website
Trial related presentations / publications
Wallingford SC, van As JA, Hughes MC, Green AC, van der Pols JC. Plasma omega-3 and omega-6 concentrations and risk of cutaneous basal and squamous cell carcinomas in Australian adults. Cancer Epidemiol Biomarkers Prev 2013; 22: 1900-5.

von Schuckmann LA, Hughes M, Green AC, van der Pols JC. Forearm hair density and risk of keratinocyte cancers in Australian adults. Arch Dermatol Res 2016; 308: 617-24.

Miura K, Hughes MCB, Ungerer JPJ, Green AC. Plasma eicosapentaenoic acid is negatively associated with all-cause mortality among men and women in a population-based prospective study. Nutr Research 2016; 36: 1202-09.

Iannacone MR, Hughes MC, Green AC. Effects of sunscreen on skin cancer and photoaging. Photodermatol Photoimmunol Photomed. 2014; 30:55-61.

Public notes

Contacts
Principal investigator
Name 30668 0
Prof Adele C Green
Address 30668 0
QIMR Berghofer Medical Research Institute
300 Herston Road, Herston QLD 4006
Country 30668 0
Australia
Phone 30668 0
+61-7-33620234
Fax 30668 0
Email 30668 0
[email protected]
Contact person for public queries
Name 13915 0
Prof Adele Green
Address 13915 0
QIMR
PO Royal Brisbane Hospital
Qld 4029
Country 13915 0
Australia
Phone 13915 0
+61-7-33620234
Fax 13915 0
+61-7-38453503
Email 13915 0
[email protected]
Contact person for scientific queries
Name 4843 0
Prof Adele Green
Address 4843 0
QIMR
PO Royal Brisbane Hospital
Qld 4029
Country 4843 0
Australia
Phone 4843 0
+61-7-33620234
Fax 4843 0
Email 4843 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
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