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Food Reward in Cachexia Induced by Acute or Chronic Disease

Terminated
Conditions
Chronic Obstructive Pulmonary Disease
Cachexia
Non-small Cell Lung Cancer
Pancreatic Cancer
Interventions
Other: Functional magnetic resonance imaging (fMRI)
Registration Number
NCT02798003
Lead Sponsor
Maastricht University Medical Center
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
44
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Cachectic COPD patientsFunctional magnetic resonance imaging (fMRI)Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The study participants will undergo fMRI scanning.
Cachectic cancer patientsFunctional magnetic resonance imaging (fMRI)Cachectic cancer patients, including non-small cell lung cancer (NSCLC) and gastro-intestinal cancer. The study participants will undergo fMRI scanning.
Non-cachectic COPD patientsFunctional magnetic resonance imaging (fMRI)Diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The study participants will undergo fMRI scanning.
Non-cachectic cancer patientsFunctional magnetic resonance imaging (fMRI)Non-cachectic cancer patients, including NSCLC and gastro-intestinal cancer. The study participants will undergo Functional magnetic resonance imaging (fMRI) scanning.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Blood parameters: leptin (ug/L)2 years
Blood parameters: ghrelin (pg/mL)2 years
Dietary intake assessed by a food diary2 years
Blood parameters: glucose (mmol/L)2 years
Blood parameters: insulin (pmol/L)2 years
Blood parameters: glucagon-like peptide-1 (pmol/L)2 years

Trial Locations

Locations (1)

Maastricht UMC

🇳🇱

Maastricht, Limburg, Netherlands

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