Cachexia, Neoplasms, Pulmonary Disease, Chronic Obstructive, Pancreatic Neoplasms
Conditions
Brief summary
To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease.
Detailed description
This is a prospective, cross-sectional study to determine BAT activity in cachectic patients with pancreatic or non-small cell lung cancer, and in cachectic patients with chronic obstructive pulmonary disease (COPD), and compare results with healthy individuals and non-cachectic COPD patients, matched for age and BMI.
Interventions
DEVICEAccelerometry
Physical activity level: accelerometry.
RADIATION18F-FDG PET-MRI-imaging
BAT activity: 18F-FDG PET-MRI-imaging.
RADIATIONDXA scanning
Body composition: DXA scanning, D2O and MRI.
Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.
PROCEDUREBlood sampling
Systemic inflammatory profile: blood sampling.
OTHERIndirect calorimetry
Resting metabolic rate: indirect calorimetry.
OTHERDouble-labeled water
Body composition: DXA scanning, D2O and MRI. Total daily energy expenditure: double-labeled water.
Sponsors
Maastricht University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pancreatic cancer patients, or NSCLC cancer patients, or COPD patients * The diagnostic criterion for cachexia is unintentional weight loss more than 5% over the past 6 months or more than 2% in individuals with a body-mass index \< 20 kg/m2 and muscle wasting assessed by DXA; * Age ≥ 30 years; * Gender: male and female; * Caucasians.
Exclusion criteria
* Uncontrolled Diabetes Mellitus; * Patients with severe clotting disorder; * Patients with an active second malignancy; * Psychological unstable persons presumed unfit to perform the measurements, including claustrophobia; * Persons unable to lie or sit still for 1-2 hours; * Oxygen therapy; * Pregnant subjects;Subjects unable to undergo MRI (e.g. pacemaker; neurostimulator; implantable cardioverter-defibrillator (ICD) or leads; Foley bladder catheter; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; vascular clips; denture, which contains magnets); * Subjects that received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history; * 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 anti-depressives), reserpine, cocaine, calciumblockers, labetalol, and certain tranquillizers (fenothiazines).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brown adipose tissue (BAT) activity measured by PET(-MRI) | participants will be followed for 2 weeks | The main endpoint of this study is BAT volume and intensity of activity in Standard Uptake Value (SUV) in the presence of cancer cachexia, COPD cachexia, and compared to non-cachectic COPD patients and healthy individuals, as assessed by 18F-fluoro-deoxyglucose (18F-FDG) PET-MRI scanning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting metabolic rate measured by REE | participants will be followed for 2 weeks | — |
| Metabolic gene expression in WAT measured by biopsy of subcutaneous fat | participants will be followed for 2 weeks | — |
| Systemic inflammatory status measured in blood | participants will be followed for 2 weeks | — |
| Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water | participants will be followed for 2 weeks | — |
| Hormonal status measured in blood | participants will be followed for 2 weeks | — |
| Lean tissue mass measured by MRI, DXA, and doubly labeled water | participants will be followed for 2 weeks | Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA) |
| Fat tissue mass measured by MRI, DXA, and doubly labeled water | participants will be followed for 2 weeks | Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA) |
Countries
Netherlands
Outcome results
None listed