Food Reward in Cachexia Induced by Acute or Chronic Disease

NCT ID: NCT02798003

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2022-02-18

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cachectic cancer patients

Cachectic cancer patients, including non-small cell lung cancer (NSCLC) and gastro-intestinal cancer. The study participants will undergo fMRI scanning.

Functional magnetic resonance imaging (fMRI)

Intervention Type: OTHER

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.

Non-cachectic cancer patients

Non-cachectic cancer patients, including NSCLC and gastro-intestinal cancer. The study participants will undergo Functional magnetic resonance imaging (fMRI) scanning.

Functional magnetic resonance imaging (fMRI)

Intervention Type: OTHER

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.

Cachectic COPD patients

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.

Functional magnetic resonance imaging (fMRI)

Intervention Type: OTHER

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.

Non-cachectic COPD patients

Diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The study participants will undergo fMRI scanning.

Functional magnetic resonance imaging (fMRI)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annemie Schols, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC

Locations

Maastricht UMC

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

NL54799.068.15

Identifier Type: -

Identifier Source: org_study_id