Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12613000976785
Ethics application status
Approved
Date submitted
13/08/2013
Date registered
2/09/2013
Date last updated
2/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective analysis of the nutritional status of chemoradiotherapy patients
Scientific title
Prospective analysis of the nutritional status of chemoradiotherapy patients
Secondary ID [1] 283011 0
Nil Known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutritional status in Chemo-radiotherpeutic patients 289837 0
Condition category
Condition code
Diet and Nutrition 290193 290193 0 0
Other diet and nutrition disorders
Cancer 290334 290334 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All eligible patients attending the Alan Cancer Care Centre will be consented for participation into this study. Each participant’s nutritional status will be assessed at baseline, first week of treatment, then final week of treatment, and finally at 1-month post treatment using a validated malnutrition assessment tool, the Patient Generated-Subjective Global Assessment. The Patient Generated-Subjective Global Assessment is a validated malnutrition assessment tool for cancer patients.
Intervention code [1] 287726 0
Not applicable
Comparator / control treatment
Indigenous and non-Indigenous chemo-radiotherapy patients
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290223 0
Identification of the malnutrition prevalence at AWCCC amongst chemo-radiotherapy patients. It would be assessed using a validated malnutrition assessment tool, the Patient Generated-Subjective Global Assessment.

Timepoint [1] 290223 0
July 2013 - July 2014
Secondary outcome [1] 304150 0
To contribute new knowledge in the area of oncology nutrition as no published data currently exists for NT hospitals and hospitals with a large proportion of Indigenous people in the demographic
Timepoint [1] 304150 0
August 2014 - Dec 2015

Eligibility
Key inclusion criteria
18 years or over undergoing curative intent chemo-radiotherapy at Alan Walker Cancer Care Centre (AWCCC)
Able to speak basic English or have an interpreter present
Able to provide consent
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or breast feeding women
Non-English speaking background where interpreter not available
Change to single modality treatment (i.e. change from chemo-radiotherapy to chemotherapy or radiotherapy alone) or change to treatment intent (i.e. change from curative intent to palliative intent)
Violent or aggressive patients to maintain the safety of investigators

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Prevalence data will be analysed using percentages (e.g. percentage of patients who were malnourished), while comparative data will be analysed using chi-square tests (e.g. are Indigenous or non-Indigenous patients more likely to be malnourished), and on the other hand linear regression analysis of the PG-SGA scores will be established using SPSS version 20 (IBM SPSS).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
15/07/2013
Date of last participant enrolment
Anticipated
30/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 1440 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 7272 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 287778 0
University
Name [1] 287778 0
Charles Darwin University
Country [1] 287778 0
Australia
Primary sponsor type
Hospital
Name
Royal Darwin Hospital
Address
Louise Moodie,
Department of Nutrition and Dietetics,
Royal Darwin Hospital
Rocklands Drive
Tiwi
NT -0810
Country
Australia
Secondary sponsor category [1] 286505 0
Individual
Name [1] 286505 0
Dr Rama Jayaraj
Address [1] 286505 0
Lecturer - Clinical Sciences
School of Psychological and Clinical Sciences,
Charles Darwin University
Casuriana
NT -0909
Country [1] 286505 0
Australia
Secondary sponsor category [2] 286506 0
Individual
Name [2] 286506 0
Dr. Siddhartha Baxi
Radiation Oncologist (RANZCR)
Address [2] 286506 0
Postal: PO BOX 183
Gelorup 6230
Western Australia
Australia

Location: Southwest Health Campus
Bussell Highway (cnr Robertson Drive)
Bunbury 6230
Western Australia
Country [2] 286506 0
Australia
Secondary sponsor category [3] 286507 0
Individual
Name [3] 286507 0
Mr Bahati Mbuzukongira
Address [3] 286507 0
School of Psychological and Clinical Sciences,
Charles Darwin University
Casuariana
NT-0909
Country [3] 286507 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289728 0
Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 289728 0
Menzies School of Health Research
Bldg 58
Royal Darwin Hospital Campus
TIWI
NT -0810
Ethics committee country [1] 289728 0
Australia
Date submitted for ethics approval [1] 289728 0
05/06/2013
Approval date [1] 289728 0
19/06/2013
Ethics approval number [1] 289728 0
HREC2013 1973

Summary
Brief summary
The study aims to evaluate the nutritional status of chemo-radiotherapy patients. Who is it for? You may be eligible to join this study if you are aged 18 years or over and are undergoing curative intent chemo-radiotherapy at the Alan Walker Cancer Care Centre in Darwin, Northern Territory. Trial details All participants in this study will have their nutritional status assessed at baseline, first week of treatment, then final week of treatment, and finally at 1-month post treatment using the Patient Generated-Subjective Global Assessment. This is a validated malnutrition assessment tool for cancer patients. This study aims to baseline the nutritional status of chemo-radiotherapy patients undergoing treatment at the Alan Walker Cancer Care Centre (Darwin), identify contributors to nutritional deterioration and determine if there is a difference between Indigenous and non-Indigenous patients. This study will provide a prospective analysis of malnutrition and a clear insight of nutritional status of cancer patients. This study will be the first of its kind to address the nutritional status of cancer patients in Indigenous Australians.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42122 0
Miss Louise Moodie
Address 42122 0
Royal Darwin Hospital
Rocklands Drive
Tiwi
NT -0810
Country 42122 0
Australia
Phone 42122 0
+61 8 8922 7920
Fax 42122 0
+ 61 8 8922 7709
Email 42122 0
[email protected]
Contact person for public queries
Name 42123 0
Rama Jayaraj
Address 42123 0
School of Psychological and Clinical Sciences
Charles Darwin University
Tiwi
NT-0810
Country 42123 0
Australia
Phone 42123 0
+61 410541300
Fax 42123 0
+61 8 8946 7474
Email 42123 0
[email protected]
Contact person for scientific queries
Name 42124 0
Rama Jayaraj
Address 42124 0
School of Psychological and Clinical Sciences
Charles Darwin University
Tiwi
NT-0810
Country 42124 0
Australia
Phone 42124 0
61 410541300
Fax 42124 0
+61 8 8946 7474
Email 42124 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
No additional documents have been identified.