Clinical trial NCT02798003: Food Reward in Cachexia Induced by Acute or Chronic Disease
Official title: Analysis of Food Reward System in Cachexia Induced by Acute or Chronic Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cachexia
Chronic Obstructive Pulmonary Disease
Non-small Cell Lung Cancer
Pancreatic Cancer
Keywords: Cachexia
Food reward
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Four groups will be included:

1. Cachectic cancer patients, including NSCLC and gastro-intestinal cancer
2. Non-cachectic cancer patients, including NSCLC and gastro-intestinal cancer
3. Cachectic COPD patients
4. Non-cachectic COPD patients

Individuals of all groups will be gender and age matched. In addition, COPD patients will be matched for FEV1.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Dietary intake assessed by a food diary
timeFrame: 2 years
measure: Blood parameters: glucose (mmol/L)
timeFrame: 2 years
measure: Blood parameters: insulin (pmol/L)
timeFrame: 2 years
measure: Blood parameters: leptin (ug/L)
timeFrame: 2 years
measure: Blood parameters: ghrelin (pg/mL)
timeFrame: 2 years
measure: Blood parameters: glucagon-like peptide-1 (pmol/L)
timeFrame: 2 years
Other outcomes:
measure: Anthropometrical characteristics: body mass index (kg/m2)
timeFrame: 2 years
measure: Other relevant co-variables: current medical status (charlson co-morbidity index scale)
timeFrame: 2 years
measure: Other relevant co-variables: World Health Organization performance score (WHO PS)
timeFrame: 2 years
measure: Other relevant co-variables: pulmonary function (Forced Expiration Volume in 1 second [FEV1] in % predicted)
timeFrame: 2 years
measure: Other relevant co-variables: pulmonary function (diffusing capacity of the lungs for carbon monoxide [DLCO] in % predicted)
timeFrame: 2 years
measure: Other relevant co-variables: weight change past 6 months (kg)
timeFrame: 2 years
measure: Other relevant co-variables: self-reported smoking status of all 44 participants (current, former, never, in pack years)
timeFrame: 2 years
measure: Changes in food preferences assessed by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT)
timeFrame: 2 years
measure: Cognitive functioning assessed by Mini-Mental State Examination (MMSE)
timeFrame: 2 years
measure: Cognitive functioning assessed by Cognitive Failure Questionnaire (CFQ)
timeFrame: 2 years
measure: Presence of depression and anxiety assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 2 years
measure: General wellbeing assessed by the European Organization for Research and Treatment of Cancer (EORTC) c30 questionnaire
timeFrame: 2 years
measure: Inflammatory parameters: c-reactive protein (ml/L)
timeFrame: 2 years
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
state: Limburg
Study officials:
affiliation: Maastricht UMC
name: Annemie Schols, PhD
role: PRINCIPAL_INVESTIGATOR
References: