Cachexia, Chronic Obstructive Pulmonary Disease, Non-small Cell Lung Cancer, Pancreatic Cancer
Conditions
Keywords
Cachexia, Food reward
Brief summary
To study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease.
Detailed description
The activity in the food reward-circuitry of the brain in patients suffering from cachexia induced by cancer (lung cancer or pancreatic cancer) or chronic disease (chronic obstructive pulmonary disease) will be analysed by using functional magnetic resonance imaging. In addition, the role of the peripheral satiety hormones will be evaluated.
Interventions
The food-cue elicited response in the reward-circuitry of the brain will be assessed by using fMRI. This technique is based on different magnetic properties of oxygenated and deoxygenated blood. Increased neuronal activity causes an increase in blood flow. Thereby, neuronal activity is indirectly reflected by changes in blood oxygenation level-dependent (BOLD) contrast.
Sponsors
Study design
Eligibility
Inclusion criteria
* For cachectic patients: weight loss exceeds 5% of total body weight over the past 6 months, or \>2% when body mass index is \<20 kg/m2 * For non-cachectic patients: no weight loss of ≥5% during the last 6 months * Non-small cell lung cancer or gastro-intestinal cancer, pathology proven or diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
Exclusion criteria
* Contra-indications for fMRI examination (operation to your head or brain in the past; implanted electronic devices, for instance a pacemaker, neurostimulator, cochlear or hearing implant; insulin pump under your skin; Pregnant subjects, claustrophobia; pregnancy; metal parts in your body (except from teeth filling and connectors): implants; brain vessel clamps, prostheses, intra-uterine device, metal splinter in the eye, metal braces or other metal objects, permanent eye make-up) * Psychiatric or other disorders likely to impact on informed consent * Presence of brain metastasis (screening is not mandatory) * Medical history of cerebrovascular accident, brain tumour, brain metastasis * Previous radiotherapy to brain, both stereotactic and whole brain radiotherapy * Memory problems * Current use of tube feeding or parental nutrition * Patients with an active second malignancy * Patients unable to lie still for 2 hours * Unable to complete the cognitive task * Pre-existing swallowing difficulties * Allergy to gluten-, milk- or wheat products * Self-reported hyperthyroidism * Self-reported diabetes mellitus * Current use of appetite stimulant medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reward-related activity in response to food cues, as indicated by Blood Oxygenation Level Dependent (BOLD) values in specified brain areas related to food reward. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Blood parameters: glucose (mmol/L) | 2 years |
| Blood parameters: insulin (pmol/L) | 2 years |
| Dietary intake assessed by a food diary | 2 years |
| Blood parameters: ghrelin (pg/mL) | 2 years |
| Blood parameters: glucagon-like peptide-1 (pmol/L) | 2 years |
| Blood parameters: leptin (ug/L) | 2 years |
Other
| Measure | Time frame |
|---|---|
| Changes in food preferences assessed by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) | 2 years |
| Cognitive functioning assessed by Mini-Mental State Examination (MMSE) | 2 years |
| Cognitive functioning assessed by Cognitive Failure Questionnaire (CFQ) | 2 years |
| Anthropometrical characteristics: body mass index (kg/m2) | 2 years |
| General wellbeing assessed by the European Organization for Research and Treatment of Cancer (EORTC) c30 questionnaire | 2 years |
| Inflammatory parameters: c-reactive protein (ml/L) | 2 years |
| Presence of depression and anxiety assessed by the Hospital Anxiety and Depression Scale (HADS) | 2 years |
| Other relevant co-variables: current medical status (charlson co-morbidity index scale) | 2 years |
| Other relevant co-variables: World Health Organization performance score (WHO PS) | 2 years |
| Other relevant co-variables: pulmonary function (Forced Expiration Volume in 1 second [FEV1] in % predicted) | 2 years |
| Other relevant co-variables: pulmonary function (diffusing capacity of the lungs for carbon monoxide [DLCO] in % predicted) | 2 years |
| Other relevant co-variables: weight change past 6 months (kg) | 2 years |
| Other relevant co-variables: self-reported smoking status of all 44 participants (current, former, never, in pack years) | 2 years |
Countries
Netherlands