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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04127981




Registration number
NCT04127981
Ethics application status
Date submitted
23/04/2019
Date registered
16/10/2019

Titles & IDs
Public title
Medical Imaging of Cachexia
Scientific title
A Pilot Bioimaging Trial of Cancer Cachexia
Secondary ID [1] 0 0
ONJ2018-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - 18F-FDG PET + Dexa Scan

Active comparator: Patients with cancer cachexia - 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC), or pancreatic cancer with documented cachexia.

Active comparator: Patients without cancer cachexia - 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC) or pancreatic cancer without cachexia.


Diagnosis / Prognosis: 18F-FDG PET + Dexa Scan
18F-FDG PET will be compared with Dexa Scan result within and between arms.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Correlation of a clinical diagnosis of cachexia with the metabolic activity of brown adipose tissue, bone density and muscle mass.
Timepoint [1] 0 0
7 days post enrollment
Secondary outcome [1] 0 0
Optimization of PET scanning methods for imaging of brown adipose tissue.
Timepoint [1] 0 0
7 days post enrollment
Secondary outcome [2] 0 0
To quantify change from normal of inflammatory blood biomarkers
Timepoint [2] 0 0
7 days post enrollment
Secondary outcome [3] 0 0
To quantify change from normal of immune blood biomarkers
Timepoint [3] 0 0
7 days post enrollment

Eligibility
Key inclusion criteria
* Patients with malignant disease;
* ECOG Performance score of 0-2;
* Age = 18 years;
* Life expectancy of >4 months at screening;
* Cachexia patient group only: Fulfils diagnostic criteria for cachexia: unintentional weight loss more than 5% over the previous 6 months, or more than 2% in individuals with a decreased body-mass index of <20kg/m2, or skeletal muscle wasting (sarcopenia).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with uncontrolled Diabetes Mellitus;

* Psychological unstable persons presumed unfit to perform the investigations;
* Persons unable to lie or sit still for 1-2 hours;
* Pregnant patients;
* Patients who received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history limiting nutritional intake;
* Patients who are receiving any chemotherapeutic agents which is limiting nutritional intake;
* Persons that received cervical or thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves;
* The use of medication that influences the sympathetic nerve system: ß-blockers, a-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic antidepressives), reserpine, cocaine, calcium channel blockers, labetalol, and certain tranquillizers (fenothiazines).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/12/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
3078 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
Olivia Newton-John Cancer Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
La Trobe University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Austin Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Andrew M Scott, MD
Address 0 0
Austin Health/ONJCRI
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jodie Palmer, PhD
Address 0 0
Country 0 0
Phone 0 0
0394963573
Fax 0 0
Email 0 0
jodie.palmer@onjcri.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Cohort data will be shared via journal and conference presentations


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/NCT04127981