Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-03-28
2023-12-28
Brief Summary
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Detailed Description
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Patients willbe assessed for sarcopenia using a dual energy X-ray absorptiometry or bone densitometry scan (DXA). Given the variables which may affect uptake of BAT in cancer patients, this study will standardise patient preparation and PET scan procedure in order to obtain the most reliable assessment of BAT activity in all patients on study.
It is hypothesisd that use of this PET imaging technique, which is part of standard care to assess cancer progression, may assist clinicians in early identification of metabolic changes in a patient, with potential for early intervention and utility in monitoring success of treatments of cachexia.
A total of 40 patients will be evaluated, 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC) or pancreatic cancer without cachexia, and 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC), or pancreatic cancer with documented cachexia, all of whom are referred for standard of care 18F-FDG PET scans.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Patients with cancer cachexia
20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC), or pancreatic cancer with documented cachexia.
18F-FDG PET + Dexa Scan
18F-FDG PET will be compared with Dexa Scan result within and between arms.
Patients without cancer cachexia
20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC) or pancreatic cancer without cachexia.
18F-FDG PET + Dexa Scan
18F-FDG PET will be compared with Dexa Scan result within and between arms.
Interventions
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18F-FDG PET + Dexa Scan
18F-FDG PET will be compared with Dexa Scan result within and between arms.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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, α-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic antidepressives), reserpine, cocaine, calcium channel blockers, labetalol, and certain tranquillizers (fenothiazines).
18 Years
ALL
No
Sponsors
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La Trobe University
OTHER
Austin Health
OTHER_GOV
Olivia Newton-John Cancer Research Institute
OTHER
Responsible Party
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Principal Investigators
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Andrew M Scott, MD
Role: PRINCIPAL_INVESTIGATOR
Austin Health/ONJCRI
Locations
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Austin Health
Heidelberg, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ONJ2018-002
Identifier Type: -
Identifier Source: org_study_id
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