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
Cancer patients are one of the patient groups at highest risk for the development of malnutrition. Anti-cancer treatments, such as chemotherapy and radiotherapy, can further heighten the risk due to the nutrition-related toxicities experienced during this time.

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.
Trial website
https://clinicaltrials.gov/study/NCT01937273
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01937273