Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-28 @ 10:09 AM
Study NCT ID:
NCT03141957
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypermetabolism in the Elderly Lung Cancer Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measured resting energy expenditure (mREE) in kilocalorie per day', 'timeFrame': 'Day 0', 'description': 'Energy expenditure is measured by indirect calorimetry.'}], 'secondaryOutcomes': [{'measure': 'Blood C-Reactive Protein in milligram per milliliter', 'timeFrame': 'Day 0', 'description': 'Inflammatory status'}, {'measure': 'Blood Interleukine-6 in picogram per milliliter', 'timeFrame': 'Day 0', 'description': 'Inflammatory status'}, {'measure': 'Blood Tumor Necrosis Factor alpha in picogram per milliliter', 'timeFrame': 'Day 0', 'description': 'Inflammatory status'}, {'measure': 'Blood Insulin in milliunit per liter', 'timeFrame': 'Day 0', 'description': 'Endocrine Status - Glucose Homeostasis'}, {'measure': 'Blood ultra-sensitive Thyroid Stimulating Hormone in milliunit per liter', 'timeFrame': 'Day 0', 'description': 'Endocrine Status - Thyroid Function'}, {'measure': 'Blood Insulin-like Growth Factor 1 in nanogram per liter', 'timeFrame': 'Day 0', 'description': 'Endocrine Status - Somatotropic axis'}, {'measure': 'Blood Glucose in millimole per liter', 'timeFrame': 'Day 0', 'description': 'Endocrine Status'}, {'measure': 'Homeostasis Model assessment of Insulin resistance', 'timeFrame': 'Day 0', 'description': 'Aggregates blood Insulin and glucose level as an insulin resistance score'}, {'measure': 'Lean Body Mass in kilogram', 'timeFrame': 'Day 0', 'description': 'Estimated from muscular area at the third lombular vertebra from CT-scan'}, {'measure': 'energy intake in kilocalorie per day', 'timeFrame': 'Day 0', 'description': 'Estimated by a qualified dietetican'}, {'measure': 'Albumin in gram per liter', 'timeFrame': 'Day 0', 'description': 'Nutritional Satus'}, {'measure': 'Transthyretin in gram per liter', 'timeFrame': 'Day 0', 'description': 'Nutritional Satus'}, {'measure': 'Predicted resting energy expenditure (HB) in kilocalorie per day', 'timeFrame': 'Day 0', 'description': 'REE estimated with Harris \\& Benedict Formula'}, {'measure': 'Percentage of estimated energy expenditure', 'timeFrame': 'Day 0', 'description': 'Percentage of HB : (mREE/HB) x 100'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aging', 'Hypermetabolism'], 'conditions': ['Non-small Cell Lung Carcinoma']}, 'referencesModule': {'references': [{'pmid': '31865308', 'type': 'DERIVED', 'citation': 'Ulmann G, Jouinot A, Tlemsani C, Curis E, Kousignian I, Neveux N, Durand JP, Goldwasser F, Cynober L, De Bandt JP. Lean Body Mass and Endocrine Status But Not Age Are Determinants of Resting Energy Expenditure in Patients with Non-Small Cell Lung Cancer. Ann Nutr Metab. 2019;75(4):223-230. doi: 10.1159/000504874. Epub 2019 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'Aging and cancer are two conditions associated with extensive metabolic changes that can cause malnutrition. However, the clinical features and the underlying mechanisms leading to malnutrition are different in these two cases. We therefore wonder how age can influence the metabolic response to cancer.', 'detailedDescription': 'During aging, among other physiological modifications, inactivity and insulin resistance cause a progressive muscle loss associated with a decrease in resting energy expenditure (REE). In cancer, loud inflammation background also provokes a decrease in muscle mass as well as in fat mass. However, previous studies reported an increased REE, termed hypermetabolism, probably linked to inflammation.\n\nData concerning response to aggression in the elderly patient is scarce and even inexistent when it comes to cancer. The investigators hypothesize that the mitochondrial dysfunction that comes with aging and that decreases the ATP rendering per unit of energy-producing nutrient oxidized increases the amount of nutrient to be consumed in order to sustain to energy needs. Therefore, in this situation, elderly patients could have a higher rate or degree of hypermetabolism than younger patients.\n\nThe primary objective of this study is to assess the effect of aging on the metabolic response to cancer assessed by resting energy expenditure measured by indirect calorimetry corrected by whole body fat free mass calculated from single slice CT imaging at the third lumbar vertebra.\n\nThe secondary objective of this study is to point out some inflammatory or endocrine determinants of these energy metabolism changes in the cancer patient.\n\nNon-small cell lung carcinoma seems to be a relevant choice for this study because it is frequently associated with cachexia and the literature reports a high rate of hypermetabolism in this cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population is selected from the patients coming for their one-day pre-treatment evaluation at the oncology ward of the Cochin Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-small cell lung carcinoma\n\nExclusion Criteria:\n\n* Imbalanced Diabetes\n* Imbalanced dysthyroidia\n* Surgery within two month prior inclusion\n* Any chronic auto-immune or inflammatory disease'}, 'identificationModule': {'nctId': 'NCT03141957', 'acronym': 'HELP', 'briefTitle': 'Hypermetabolism in the Elderly Lung Cancer Patient', 'organization': {'class': 'OTHER', 'fullName': 'University of Paris 5 - Rene Descartes'}, 'officialTitle': 'Hypermetabolism in the Elderly Lung Cancer Patient', 'orgStudyIdInfo': {'id': 'LBN001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young patients', 'description': 'Patients with non-small cell lung carcinoma younger than 75y'}, {'label': 'Elderly patients', 'description': 'Patients with non-small cell lung carcinoma aged 75 or more'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Paris 5 - Rene Descartes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Guillaume Ulmann', 'investigatorAffiliation': 'University of Paris 5 - Rene Descartes'}}}}