Cancer Cachexia
Conditions
Keywords
18F-FDG PET Scan, Dexa Scan, Quality of Life assessment tools
Brief summary
This is a pilot trial using 18F-FDG PET and DXA scans to determine whether these investigations are objective tools to assess cachexia.
Detailed description
This pilot study will establish the differences in BAT uptake of 18F-FDG in cachectic and non-cachectic cancer patients using PET imaging. 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.
Interventions
DIAGNOSTIC_TEST18F-FDG PET + Dexa Scan
18F-FDG PET will be compared with Dexa Scan result within and between arms.
Sponsors
La Trobe University
Austin Health
Olivia Newton-John Cancer Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
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, α-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic antidepressives), reserpine, cocaine, calcium channel blockers, labetalol, and certain tranquillizers (fenothiazines).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of a clinical diagnosis of cachexia with the metabolic activity of brown adipose tissue, bone density and muscle mass. | 7 days post enrollment | Quantitation of the metabolic activity of brown adipose tissue, bone density and muscle mass using 18F-FDG uptake and bone densitometry will be correlated with a diagnosis of clinical cachexia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optimization of PET scanning methods for imaging of brown adipose tissue. | 7 days post enrollment | Optimization of the patient environment (ie. ambient temperature) and metabolic state (ie. Heart rate, dietary state) to minimize the impact of these factors and allow direct comparison of metabolic activity of brown adipose tissue between cachectic and non-cachectic patients. |
| To quantify change from normal of inflammatory blood biomarkers | 7 days post enrollment | To validate change from normal laboratory range of inflammatory blood based proteins and enzymes in cachectic vs non-cachectic patients. |
| To quantify change from normal of immune blood biomarkers | 7 days post enrollment | To validate change from normal laboratory range immune blood based proteins and enzymes in cachectic vs non-cachectic patients. |
Countries
Australia
Contacts
Primary ContactJodie Palmer, PhD
Backup ContactFiona Scott
Outcome results
None listed