Food Reward in Cachexia Induced by Acute or Chronic Disease

NCT02798003 | Terminated DMC

• 1 other identifier: NL54799.068.15
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Cachexia; Food reward

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Dietary intake assessed by a food diary

  2 years

• Blood parameters: glucose (mmol/L)

  2 years

• Blood parameters: insulin (pmol/L)

  2 years

• Blood parameters: leptin (ug/L)

  2 years

• Blood parameters: ghrelin (pg/mL)

  2 years

Other Outcomes (13)

• Anthropometrical characteristics: body mass index (kg/m2)

  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

Study Arms (4)

Cachectic cancer patients

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

Other: Functional magnetic resonance imaging (fMRI)

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.

Other: Functional magnetic resonance imaging (fMRI)

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.

Other: Functional magnetic resonance imaging (fMRI)

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.

Other: Functional magnetic resonance imaging (fMRI)

Interventions

Functional magnetic resonance imaging (fMRI) 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; Cachectic cancer patients; Non-cachectic COPD patients; Non-cachectic cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC

Maastricht, Limburg, 6200MD, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Cachexia; Pulmonary Disease, Chronic Obstructive; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Annemie Schols, PhD

  Maastricht UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: June 14, 2016
• Study Start: December 1, 2016
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

NL (1)