Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-20 @ 8:09 PM
Study NCT ID:
NCT02798003
Status:
TERMINATED
Last Update Posted:
2024-08-06
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Reward in Cachexia Induced by Acute or Chronic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Not feasible to include the needed patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-02', 'studyFirstSubmitDate': '2016-03-31', 'studyFirstSubmitQcDate': '2016-06-08', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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'}], 'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cachexia', 'Food reward'], 'conditions': ['Cachexia', 'Chronic Obstructive Pulmonary Disease', 'Non-small Cell Lung Cancer', 'Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'To study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Four groups will be included:\n\n1. Cachectic cancer patients, including NSCLC and gastro-intestinal cancer\n2. Non-cachectic cancer patients, including NSCLC and gastro-intestinal cancer\n3. Cachectic COPD patients\n4. Non-cachectic COPD patients\n\nIndividuals of all groups will be gender and age matched. In addition, COPD patients will be matched for FEV1.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* For non-cachectic patients: no weight loss of ≥5% during the last 6 months\n* 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\n\nExclusion Criteria:\n\n* 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)\n* Psychiatric or other disorders likely to impact on informed consent\n* Presence of brain metastasis (screening is not mandatory)\n* Medical history of cerebrovascular accident, brain tumour, brain metastasis\n* Previous radiotherapy to brain, both stereotactic and whole brain radiotherapy\n* Memory problems\n* Current use of tube feeding or parental nutrition\n* Patients with an active second malignancy\n* Patients unable to lie still for 2 hours\n* Unable to complete the cognitive task\n* Pre-existing swallowing difficulties\n* Allergy to gluten-, milk- or wheat products\n* Self-reported hyperthyroidism\n* Self-reported diabetes mellitus\n* Current use of appetite stimulant medications'}, 'identificationModule': {'nctId': 'NCT02798003', 'briefTitle': 'Food Reward in Cachexia Induced by Acute or Chronic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Analysis of Food Reward System in Cachexia Induced by Acute or Chronic Disease', 'orgStudyIdInfo': {'id': 'NL54799.068.15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cachectic cancer patients', 'description': 'Cachectic cancer patients, including non-small cell lung cancer (NSCLC) and gastro-intestinal cancer. The study participants will undergo fMRI scanning.', 'interventionNames': ['Other: Functional magnetic resonance imaging (fMRI)']}, {'label': 'Non-cachectic cancer patients', 'description': 'Non-cachectic cancer patients, including NSCLC and gastro-intestinal cancer. The study participants will undergo Functional magnetic resonance imaging (fMRI) scanning.', 'interventionNames': ['Other: Functional magnetic resonance imaging (fMRI)']}, {'label': 'Cachectic COPD patients', 'description': '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.', 'interventionNames': ['Other: Functional magnetic resonance imaging (fMRI)']}, {'label': 'Non-cachectic COPD patients', 'description': 'Diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The study participants will undergo fMRI scanning.', 'interventionNames': ['Other: Functional magnetic resonance imaging (fMRI)']}], 'interventions': [{'name': 'Functional magnetic resonance imaging (fMRI)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Cachectic COPD patients', 'Cachectic cancer patients', 'Non-cachectic COPD patients', 'Non-cachectic cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200MD', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht UMC', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Annemie Schols, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht UMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}