Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001279617
Ethics application status
Approved
Date submitted
18/11/2014
Date registered
5/12/2014
Date last updated
5/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Body composition assessment of children undergoing treatment for cancer
Scientific title
Study to examine the body composition of children undergoing treatment for cancer
Secondary ID [1] 285692 0
Nil known
Universal Trial Number (UTN)
U1111-1164-1982
Trial acronym
NAT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 293549 0
Condition category
Condition code
Cancer 293826 293826 0 0
Children's - Leukaemia & Lymphoma
Cancer 293827 293827 0 0
Children's - Brain
Cancer 293828 293828 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
All children participating in the study will have their height and weight measured on arrival at the centre. The Paediatric Oncology Assessment Tool will be completed before any body composition measurements are taken. Mid arm circumferences will be taken using a tape measure and following standard guidelines. Skinfolds will be measured using calibrated calipers and following the strict standard site protocol. Measurements will be taken at the biceps, triceps, subscapular and suprailiac sites.

Total body potassium (TBK) analysis will be performed using a shadow shield whole-body counter (Accuscan, Canberra Industries, MA, USA), which contains three sodium iodide crystal scintillation detectors arranged above a scanning bed. The crystals detect the 1.46MeV gamma rays being emitted by the potassium-40 (40K) found in the body. As a fixed proportion of the body’s potassium occurs as the natural isotope 40K, TBK can be determined. The measurement of TBK will require the subject to lie supine on a bed that is moved under the detectors. Two 1100sec scans will be performed for each subject with all personal metallic objects having been removed. Background and sensitivity checks will be completed daily and considered in each measurement, with TBK in grams being reported. Body cell mass (BCM) will then be calculated from TBK and adjusted for body size (BCM/HTp). BCM/HTp will be expressed as a Z score relative to laboratory reference data.

ADP measurement will be performed using the Bod Pod (registered trademark) Body Composition System, adhering to the manufacturer’s instructions (Life Measurement Inc, Concord, CA, USA; software version 1.69). Prior to each measurement, the Bod Pod will be calibrated at zero litres and with a standard calibration cylinder of 50 litres. The child is required to wear a swimming costume and swimming cap (both may be provided by the laboratory, specially laundered, if the child does not have their own) during the test. Body volume measurements will be taken as the subject sits inside the chamber for a 50 second period. The measurement will be completed twice or until the body volume measurements are within 150ml or 0.2% of each other, whichever was the smallest (maximum of three attempts). The average of the two successful measurements will be taken. The thoracic gas volume is then measured using the Bod Pod while the child breaths into a disposable tube. The ADP measurement will take approximately 10 minutes. Percent fat measurement will be estimated from the body volume measurements, using child specific equations.
All testing will take place during 1 visit and take approximately 1.5 hours.
Intervention code [1] 290632 0
Not applicable
Comparator / control treatment
Patients will be compared to age and sex healthy matched controls
Control group
Active

Outcomes
Primary outcome [1] 293610 0
Body Cell Mass using total body potassium counting
Timepoint [1] 293610 0
During treatment - Cross-sectional study
Primary outcome [2] 293611 0
Percent Fat using air displacement plethysmography (bodpod)
Timepoint [2] 293611 0
During treatment - cross sectional study
Primary outcome [3] 293612 0
Body Mass Index
Timepoint [3] 293612 0
During Treatment - cross sectional study
Secondary outcome [1] 311469 0
Nil
Timepoint [1] 311469 0
Nil

Eligibility
Key inclusion criteria
1) Being treated for cancer at Royal Children's Hospital
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
2) Too unwell to undergo testing

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/12/2004
Date of last participant enrolment
Anticipated
Actual
8/05/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3153 0
Royal Children's Hospital - Herston
Recruitment postcode(s) [1] 8931 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 290262 0
University
Name [1] 290262 0
Children's Nutrition Research Centre, The University of Queensland
Country [1] 290262 0
Australia
Primary sponsor type
Individual
Name
Dr Alexia Murphy
Address
Children's Nutrition Research Centre
Level 4 RCHF Building
Herston Rd
RCH, Herston QLD, 4029
Country
Australia
Secondary sponsor category [1] 289043 0
Individual
Name [1] 289043 0
Prof Peter Davies
Address [1] 289043 0
Children's Nutrition Research Centre
Level 4 RCHF Building
Herston Rd
RCH, Herston QLD, 4029
Country [1] 289043 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291963 0
Ethics committee address [1] 291963 0
Ethics committee country [1] 291963 0
Date submitted for ethics approval [1] 291963 0
Approval date [1] 291963 0
11/11/2004
Ethics approval number [1] 291963 0

Summary
Brief summary
The aim of this study is to validate the Pediatric Oncology Nutrition Assessment Tool against body composition measurements of nutritional status. Once the Tool has been validated it will play an essential part in the overall assessment of pediatric oncology patient in centers throughout Australia and assist in the prevention of severe nutritional problems in pediatric oncology patients.

Patients diagnosed with an oncological disease between the ages of 5.00 and 17.99 years will be recruited from the Royal Children’s Hospital. Caregivers will be asked to accompany the patient to the Body Composition Laboratory for approximately an hour and a half period. Firstly, the Paediatric Oncology Assessment Tool will be completed by the investigator. Height, weight, total body potassium, air displacement plethysmography, skinfolds and mid arm circumference measurements will then be taken on all patients. Children and/or parent, may choose to have all or any combination of measurements. All tests performed will be non-invasive, painless and pose no known physical risk to patients.


Trial website
Trial related presentations / publications
White M, Murphy AJ, Davies PSW. (2011). Correlation between nutrition assessment data and percent body fat via plethysmography in pediatric oncology patients. Journal of Parental and Enteral Nutrition. 35(6):715-22.

Murphy AJ, White MS, Davies PSW. (2010). Body Composition of children with cancer. American Journal of Clinical Nutrition. 92(1):55-60.

Murphy AJ, White MS, Davies PSW. (2009). The Validity of Simple Methods to Detect Malnutrition in Pediatric Oncology Patients. British Journal of Nutrition. 101(9):1388-92.
Public notes

Contacts
Principal investigator
Name 52858 0
Dr Alexia Murphy
Address 52858 0
Children's Nutrition Research Center
Level 4 RCHF Building
Herston Rd
Royal Children's Hospital Herston Qld 4029
Country 52858 0
Australia
Phone 52858 0
+61733464994
Fax 52858 0
Email 52858 0
alexia.murphy@uq.edu.au
Contact person for public queries
Name 52859 0
Dr Alexia Murphy
Address 52859 0
Children's Nutrition Research Center
Level 4 RCHF Building
Herston Rd
Royal Children's Hospital Herston QLD 4029
Country 52859 0
Australia
Phone 52859 0
+61733464994
Fax 52859 0
Email 52859 0
alexia.murphy@uq.edu.au
Contact person for scientific queries
Name 52860 0
Dr Alexia Murphy
Address 52860 0
Children's Nutrition Research Center
Level 4 RCHF Building
Herston Rd
Royal Children's Hospital
Herston QLD 4029
Country 52860 0
Australia
Phone 52860 0
+61733464994
Fax 52860 0
Email 52860 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
Dimensions AIBody composition of children with cancer during treatment and in survivorship 12015https://doi.org/10.3945/ajcn.114.099697
N.B. These documents automatically identified may not have been verified by the study sponsor.