Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT00962234
Status:
TERMINATED
Last Update Posted:
2016-02-26
First Post:
2009-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolism of Lipids in Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D003903', 'term': 'Deuterium'}, {'id': 'D017666', 'term': 'Deuterium Oxide'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006859', 'term': 'Hydrogen'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007554', 'term': 'Isotopes'}, {'id': 'D014867', 'term': 'Water'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'ethics approval not renewed by Study Group', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2009-08-17', 'studyFirstSubmitQcDate': '2009-08-18', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of hepatic de novo lipogenesis', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Measures of fat transport and availability', 'timeFrame': '9 months'}, {'measure': 'Resting metabolic rate & fat oxidation', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lipogenesis', 'Lipolysis', 'Phospholipids', 'Body Composition', 'Nutritional Status', 'Lipid Metabolism'], 'conditions': ['Lung Neoplasms', 'Cachexia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ales.ualberta.ca/afns/hnru.cfm', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The causes of failing nutrition status in advanced cancer are not well known. The way fat is moved, stored, burned or changed into other compounds may be affected and will be followed in patients using a tracer and other blood tests. The investigators hypothesize that fat loss and wasting results from low essential fatty acid availability in the body. Changes may occur in the liver that limits distribution and availability of fat to the body as an energy source or for other essential functions.', 'detailedDescription': "Weight loss in cancer is the result of breakdown of fat (lipid) and muscle protein reserves. This research will explore how people with cancer use fat in their body through the use of tracers and measures in the blood. A stable isotope of hydrogen called 'deuterium' is used to trace the production of different fats by the liver. Other methods will determine how much and what types of fat are transported around the body. Body composition will be determined by CT scan and related to fat measures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lung cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low plasma phospholipids OR low plasma ratio of triglycerides to free fatty acids\n* Recent weight loss\n* Advanced stage lung cancer (Stage 3 or 4)\n\nExclusion Criteria:\n\n* Having symptoms that may affect measures of fat metabolism (nausea, vomiting, problems swallowing, etc.)\n* Taking n-3 fatty acid supplements such as fish oil'}, 'identificationModule': {'nctId': 'NCT00962234', 'briefTitle': 'Metabolism of Lipids in Advanced Cancer', 'organization': {'class': 'OTHER', 'fullName': 'AHS Cancer Control Alberta'}, 'officialTitle': 'Metabolism of Lipids in Advanced Cancer', 'orgStudyIdInfo': {'id': 'CIHR PIN 111846/ethics 24906'}, 'secondaryIdInfos': [{'id': 'CIHR PIN 111846'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metabolism', 'description': 'Lung cancer patients who exhibit abnormalities in lipid measures.', 'interventionNames': ['Other: Blood draws', 'Biological: Oral administration of stable isotope (deuterium)', 'Procedure: Metabolic rate testing']}], 'interventions': [{'name': 'Blood draws', 'type': 'OTHER', 'description': 'Up to 4 blood draws will be required, in the amount of about 10 mL each', 'armGroupLabels': ['Metabolism']}, {'name': 'Oral administration of stable isotope (deuterium)', 'type': 'BIOLOGICAL', 'otherNames': ['C/D/N Isotopes, Deuterium Oxide, CAS No: 7789-20-0'], 'description': '1 mg deuterium-labeled water/kg body water (loading dose), and 0.5 mg/kg body water diluted in 1 L of normal water (maintenance dose) to be consumed over the following 16 hours', 'armGroupLabels': ['Metabolism']}, {'name': 'Metabolic rate testing', 'type': 'PROCEDURE', 'description': "Metabolic rate testing is a painless, non-invasive test that takes about 1h. A metabolic cart is used, which detects the amount of oxygen and carbon dioxide the body uses. Patients will lie down on a bed for 30 minutes with lights dimmed and soft music to help them relax. After 30 minutes, a canopy will be placed over the patient's head and shoulders for 30 minutes for the analysis of breath samples. This test will be performed only once for this study.", 'armGroupLabels': ['Metabolism']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Vera Mazurak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AHS Cancer Control Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AHS Cancer Control Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cross Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}