Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01937273




Registration number
NCT01937273
Ethics application status
Date submitted
29/08/2013
Date registered
9/09/2013
Date last updated
16/07/2020

Titles & IDs
Public title
The Nutritional Status of Chemo-radiotherapy Patients
Scientific title
Prospective Analysis of the Nutritional Status of Chemo-radiotherapy Patients
Secondary ID [1] 0 0
HREC2013 1973
Universal Trial Number (UTN)
Trial acronym
PANSOCRP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 0 0
Cancer 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The prevalence of malnutrition amongst chemo-radiotherapy patients
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
The incidence of the development of malnutrition during chemo-radiotherapy
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
* 18 years or over undergoing curative intent chemo-radiotherapy at AWCCC
* Able to speak basic English or have an interpreter present
* Able to provide consent
Minimum age
18 Years
Maximum age
No limit
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 (ie change from chemo-radiotherapy to chemotherapy or radiotherapy alone) or change to treatment intent (ie change from curative intent to palliative intent)
* Violent or aggressive patients to maintain the safety of investigators

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Alan Walker Cancer Care Centre - Darwin
Recruitment postcode(s) [1] 0 0
0810 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Charles Darwin University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Loise Moodie
Address 0 0
Royal Darwin Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01937273