Food Reward in Cachexia Induced by Acute or Chronic Disease

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02798003
• Other study ID #: NL54799.068.15
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2016
• Last updated: December 22, 2016
• Start date: November 2016
• Est. completion date: September 2018

Study information

• Verified date: December 2016
• Source: Maastricht University Medical Center
• Contact: Karin Sanders, MD
• Phone: 0031433884597
• Email: k.sanders[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

To study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease.

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 information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: September 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cachexia
• Carcinoma, Non-Small-Cell Lung
• Chronic Disease
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Non-small Cell Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Functional 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.

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometrical characteristics: body mass index (kg/m2)		2 years	No
Other	Other relevant co-variables: current medical status (charlson co-morbidity index scale)		2 years	No
Other	Other relevant co-variables: World Health Organization performance score (WHO PS)		2 years	No
Other	Other relevant co-variables: pulmonary function (Forced Expiration Volume in 1 second [FEV1] in % predicted)		2 years	No
Other	Other relevant co-variables: pulmonary function (diffusing capacity of the lungs for carbon monoxide [DLCO] in % predicted)		2 years	No
Other	Other relevant co-variables: weight change past 6 months (kg)		2 years	No
Other	Other relevant co-variables: self-reported smoking status of all 44 participants (current, former, never, in pack years)		2 years	No
Other	Changes in food preferences assessed by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT)		2 years	No
Other	Cognitive functioning assessed by Mini-Mental State Examination (MMSE)		2 years	No
Other	Cognitive functioning assessed by Cognitive Failure Questionnaire (CFQ)		2 years	No
Other	Presence of depression and anxiety assessed by the Hospital Anxiety and Depression Scale (HADS)		2 years	No
Other	General wellbeing assessed by the European Organization for Research and Treatment of Cancer (EORTC) c30 questionnaire		2 years	No
Other	Inflammatory parameters: c-reactive protein (ml/L)		2 years	No
Primary	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	No
Secondary	Dietary intake assessed by a food diary		2 years	No
Secondary	Blood parameters: glucose (mmol/L)		2 years	No
Secondary	Blood parameters: insulin (pmol/L)		2 years	No
Secondary	Blood parameters: leptin (ug/L)		2 years	No
Secondary	Blood parameters: ghrelin (pg/mL)		2 years	No
Secondary	Blood parameters: glucagon-like peptide-1 (pmol/L)		2 years	No