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Food Reward in Cachexia Induced by Acute or Chronic Disease

Analysis of Food Reward System in Cachexia Induced by Acute or Chronic Disease

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02798003
Enrollment
44
Registered
2016-06-14
Start date
2016-12-01
Completion date
2022-02-18
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cachexia, Chronic Obstructive Pulmonary Disease, Non-small Cell Lung Cancer, Pancreatic Cancer

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

OTHERFunctional magnetic resonance imaging (fMRI)

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

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime 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

MeasureTime frame
Blood parameters: glucose (mmol/L)2 years
Blood parameters: insulin (pmol/L)2 years
Dietary intake assessed by a food diary2 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

MeasureTime 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 questionnaire2 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026