Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614001269628
Ethics application status
Approved
Date submitted
18/11/2014
Date registered
4/12/2014
Date last updated
4/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutritional late effects of childhood cancer
Scientific title
The body composition, bone health, dietary intake, physical activity and quality of life of children, adolescents and young adults who have undergone treatment for childhood cancer.
Secondary ID [1] 285696 0
Nil
Universal Trial Number (UTN)
U1111-1164-2253
Trial acronym
NLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Cancer 293553 0
Condition category
Condition code
Cancer 293836 293836 0 0
Children's - Brain
Cancer 293837 293837 0 0
Children's - Leukaemia & Lymphoma
Cancer 293838 293838 0 0
Children's - Other

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of body composition and bone health using total body potassium, air displacement plethysmography, DXA, BIA and anthropometry.
Collection of diet intake, physical activity and quality of life through diaries and questionnaires.
There will be a single visit where measurements will be taken. Testing time will be approximately 1.5 hours. The single visit will occur any time after 2 years post treatment.
Intervention code [1] 290638 0
Not applicable
Comparator / control treatment
Compared to age and gender matched controls
Control group
Active

Outcomes
Primary outcome [1] 293617 0
Body composition will be assessed using air displacement plethysmography, bioelectrical impedance analysis, dual energy, x-ray absorptiometry and total body potassium counting.
Timepoint [1] 293617 0
One measurement at one visit - at least two year post treatment
Primary outcome [2] 293618 0
Bone Density by dual energy x-ray absorptiometry
Timepoint [2] 293618 0
One measurement at one visit - at least 2 years post treatment
Secondary outcome [1] 311477 0
Dietary Intake by 3 day diet diary
Timepoint [1] 311477 0
One measurement at one visit - At least 2 years post treatment
Secondary outcome [2] 311478 0
Physical Activity by 3 day physical activity diary
Timepoint [2] 311478 0
One measurement at one visitAt least 2 years post treatment
Secondary outcome [3] 311479 0
Quality of life - PedsQL questionaire
Timepoint [3] 311479 0
One measurement at one visit- At least 2 years post treatment

Eligibility
Key inclusion criteria
1) Treated at Royal Children's Hospital Brisbane for cancer
2) At least 2 years post active treatment
Minimum age
5 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Unable to undergo testing protocol

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/03/2012
Actual
28/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290267 0
Charities/Societies/Foundations
Name [1] 290267 0
Children's Hospital Foundation
Country [1] 290267 0
Australia
Primary sponsor type
Individual
Name
Dr Alexia Murphy
Address
Children's Nutrition Research Center
Level 4, RCHF Building
Herston Rd
Royal Children's Hospital
Herston, QLD 4029
Country
Australia
Secondary sponsor category [1] 288972 0
Individual
Name [1] 288972 0
Professor Peter Davies
Address [1] 288972 0
Children's Nutrition Research Center
Level 4, RCHF Building
Herston Rd
Royal Children's Hospital
Herston, QLD 4029
Country [1] 288972 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study will look at the body composition, bone health, quality of life, physical activity and dietary intake of childhood cancer survivors (CCS) and determine whether the use of a nutritional screening tool is indicative of nutritional status and body composition. Who is it for? You may be eligible to join this study if you are aged between 5 and 25 years, were treated at the Royal Children’s Hospital for cancer and are at least 2 years post active treatment. Study details All participants will undergo body composition and bone health examinations using techniques such as total body potassium counting, air displacement plethysmography, and dual x-ray absorptiometry. Participants will also complete questionnaires on quality of life, physical activity and dietary intake. Only one visit of approximately 1.5 hours will be required to undertake the measurement. The proposed research project will ultimately allow childhood cancer survivors to have the best chance of nutritional health, growth, quality of life and optimal health in the long term. This work has immediate clinical relevance, with expected outcomes to guide clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52878 0
Dr Alexia Murphy
Address 52878 0
Children's Nutrition Research Centre
Level 4, RCHF Building
Herston Rd
RCH
Herston QLD 4029
Country 52878 0
Australia
Phone 52878 0
+61733464994
Fax 52878 0
Email 52878 0
alexia.murphy@uq.edu.au
Contact person for public queries
Name 52879 0
Alexia Murphy
Address 52879 0
Children's Nutrition Research Centre
Level 4, RCHF Building
Herston Rd
RCH
Herston QLD 4029
Country 52879 0
Australia
Phone 52879 0
+61733464994
Fax 52879 0
Email 52879 0
alexia.murphy@uq.edu.au
Contact person for scientific queries
Name 52880 0
Alexia Murphy
Address 52880 0
Children's Nutrition Research Centre
Level 4, RCHF Building
Herston Rd
RCH
Herston QLD 4029
Country 52880 0
Australia
Phone 52880 0
+61733464994
Fax 52880 0
Email 52880 0
alexia.murphy@uq.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBody composition of children with cancer during treatment and in survivorship.2015https://dx.doi.org/10.3945/ajcn.114.099697
N.B. These documents automatically identified may not have been verified by the study sponsor.