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Food Reward in Cachexia Induced by Acute or Chronic Disease

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ClinicalTrials.gov Identifier: NCT02798003
Recruitment Status : Unknown
Verified December 2016 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : June 14, 2016
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cachexia Chronic Obstructive Pulmonary Disease Non-small Cell Lung Cancer Pancreatic Cancer Other: Functional magnetic resonance imaging (fMRI)

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.

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Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Food Reward System in Cachexia Induced by Acute or Chronic Disease
Study Start Date : November 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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.
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.

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)
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.
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.




Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Dietary intake assessed by a food diary [ Time Frame: 2 years ]
  2. Blood parameters: glucose (mmol/L) [ Time Frame: 2 years ]
  3. Blood parameters: insulin (pmol/L) [ Time Frame: 2 years ]
  4. Blood parameters: leptin (ug/L) [ Time Frame: 2 years ]
  5. Blood parameters: ghrelin (pg/mL) [ Time Frame: 2 years ]
  6. Blood parameters: glucagon-like peptide-1 (pmol/L) [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Anthropometrical characteristics: body mass index (kg/m2) [ Time Frame: 2 years ]
  2. Other relevant co-variables: current medical status (charlson co-morbidity index scale) [ Time Frame: 2 years ]
  3. Other relevant co-variables: World Health Organization performance score (WHO PS) [ Time Frame: 2 years ]
  4. Other relevant co-variables: pulmonary function (Forced Expiration Volume in 1 second [FEV1] in % predicted) [ Time Frame: 2 years ]
  5. Other relevant co-variables: pulmonary function (diffusing capacity of the lungs for carbon monoxide [DLCO] in % predicted) [ Time Frame: 2 years ]
  6. Other relevant co-variables: weight change past 6 months (kg) [ Time Frame: 2 years ]
  7. Other relevant co-variables: self-reported smoking status of all 44 participants (current, former, never, in pack years) [ Time Frame: 2 years ]
  8. Changes in food preferences assessed by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) [ Time Frame: 2 years ]
  9. Cognitive functioning assessed by Mini-Mental State Examination (MMSE) [ Time Frame: 2 years ]
  10. Cognitive functioning assessed by Cognitive Failure Questionnaire (CFQ) [ Time Frame: 2 years ]
  11. Presence of depression and anxiety assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 2 years ]
  12. General wellbeing assessed by the European Organization for Research and Treatment of Cancer (EORTC) c30 questionnaire [ Time Frame: 2 years ]
  13. Inflammatory parameters: c-reactive protein (ml/L) [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Blood serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798003


Contacts
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Contact: Karin Sanders, MD 0031433884597 k.sanders@maastrichtuniversity.nl
Contact: Judith de Vos-Geelen, MD 0031433872001 judith.de.vos@mumc.nl

Locations
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Netherlands
Maastricht UMC Recruiting
Maastricht, Limburg, Netherlands, 6200MD
Contact: Karin Sanders, MD    0031433884597    k.sanders@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Annemie Schols, PhD Maastricht UMC

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02798003     History of Changes
Other Study ID Numbers: NL54799.068.15
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Maastricht University Medical Center:
Cachexia
Food reward
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Wasting Syndrome
Chronic Disease
Cachexia
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders