Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-06 @ 7:26 PM
Study NCT ID:
NCT03245658
Status:
WITHDRAWN
Last Update Posted:
2023-12-18
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cannabis in Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D000855', 'term': 'Anorexia'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587251', 'term': 'nabiximols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Organization was changed. The staff was relocated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-10-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2018-10-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy and protein intake', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'Dietary history (% of estimated needs - NRS 2002)'}], 'secondaryOutcomes': [{'measure': 'Lean body mass', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'Bioimpedance (% of body weight, kg)'}, {'measure': 'Appetite 1', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'VAS (cm on 10 cm scale)'}, {'measure': 'Appetite 2', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'Dietary history (VAS (cm on 10 cm scale))'}, {'measure': 'Appetite 3', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'EORTC QLQ-C30 (score, standard for the Quality of Life entity)'}, {'measure': 'Appetite 4', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)'}, {'measure': 'Quality of life 1', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'EORTC QLQ-C30 (score, standard for the Quality of Life entity)'}, {'measure': 'Quality of life 2', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)'}, {'measure': 'Quality of life 3', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'VAS (VAS (cm on 10 cm scale))'}, {'measure': 'Pain 1', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'EORTC QLQ-C30 (score, standard for the Quality of Life entity)'}, {'measure': 'Pain 2', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)'}, {'measure': 'Pain 3', 'timeFrame': 'The outcome measure will be assessed at day 0 and at week 4', 'description': 'VAS (VAS (cm on 10 cm scale))'}, {'measure': 'Mortality (8 weeks)', 'timeFrame': '8 weeks', 'description': 'Patient records, national register'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasms Pancreatic', 'Cachexia; Cancer', 'Cannabis', 'Appetite Loss', 'Palliative Medicine', 'Morbidity', 'Mortality']}, 'referencesModule': {'references': [{'pmid': '16317825', 'type': 'RESULT', 'citation': 'Perras C. Sativex for the management of multiple sclerosis symptoms. Issues Emerg Health Technol. 2005 Sep;(72):1-4.'}, {'pmid': '27403414', 'type': 'RESULT', 'citation': 'Gartner S, Kruger J, Aghdassi AA, Steveling A, Simon P, Lerch MM, Mayerle J. Nutrition in Pancreatic Cancer: A Review. Gastrointest Tumors. 2016 May;2(4):195-202. doi: 10.1159/000442873. Epub 2016 Jan 8.'}, {'pmid': '18728826', 'type': 'RESULT', 'citation': 'Ware MA, Daeninck P, Maida V. A review of nabilone in the treatment of chemotherapy-induced nausea and vomiting. Ther Clin Risk Manag. 2008 Feb;4(1):99-107. doi: 10.2147/tcrm.s1132.'}, {'pmid': '12648025', 'type': 'RESULT', 'citation': 'Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.'}, {'pmid': '17566383', 'type': 'RESULT', 'citation': 'Slatkin NE. Cannabinoids in the treatment of chemotherapy-induced nausea and vomiting: beyond prevention of acute emesis. J Support Oncol. 2007 May;5(5 Suppl 3):1-9.'}, {'pmid': '23141881', 'type': 'RESULT', 'citation': 'Johnson JR, Lossignol D, Burnell-Nugent M, Fallon MT. An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics. J Pain Symptom Manage. 2013 Aug;46(2):207-18. doi: 10.1016/j.jpainsymman.2012.07.014. Epub 2012 Nov 8.'}, {'pmid': '19896326', 'type': 'RESULT', 'citation': 'Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. 2010 Feb;39(2):167-79. doi: 10.1016/j.jpainsymman.2009.06.008. Epub 2009 Nov 5.'}, {'pmid': '26883879', 'type': 'RESULT', 'citation': 'Reuter SE, Martin JH. Pharmacokinetics of Cannabis in Cancer Cachexia-Anorexia Syndrome. Clin Pharmacokinet. 2016 Jul;55(7):807-812. doi: 10.1007/s40262-015-0363-2.'}, {'pmid': '22076835', 'type': 'RESULT', 'citation': 'Gamage TF, Lichtman AH. The endocannabinoid system: role in energy regulation. Pediatr Blood Cancer. 2012 Jan;58(1):144-8. doi: 10.1002/pbc.23367.'}, {'pmid': '19587829', 'type': 'RESULT', 'citation': 'Fox KM, Brooks JM, Gandra SR, Markus R, Chiou CF. Estimation of Cachexia among Cancer Patients Based on Four Definitions. J Oncol. 2009;2009:693458. doi: 10.1155/2009/693458. Epub 2009 Jul 1.'}, {'pmid': '19883531', 'type': 'RESULT', 'citation': 'Gullett N, Rossi P, Kucuk O, Johnstone PA. Cancer-induced cachexia: a guide for the oncologist. J Soc Integr Oncol. 2009 Fall;7(4):155-69.'}, {'pmid': '20076976', 'type': 'RESULT', 'citation': 'Blum D, Omlin A, Fearon K, Baracos V, Radbruch L, Kaasa S, Strasser F; European Palliative Care Research Collaborative. Evolving classification systems for cancer cachexia: ready for clinical practice? Support Care Cancer. 2010 Mar;18(3):273-9. doi: 10.1007/s00520-009-0800-6.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4924449/', 'label': 'review'}]}, 'descriptionModule': {'briefSummary': 'Cannabinoids are known to increase appetite, but THC components have psychogenic properties too. CBD is the main component in the plant, and have only minimal psychogenic effects. The aim was to test the appetite stimulating effects of CBD in patients with pancreatic cancer in palliative treatment.', 'detailedDescription': 'Randomization of consecutive patients who wanted to participate to a daily dose of CBD or not as a supplement to the standard treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult, palliative pancreatic cancer diagnosis, weight loss \\> 5%, understand and read Danish.\n\nExclusion Criteria:\n\n* Regular use of cannabis, psychiatric disorders, alcohol abuse, life expectancy \\< 6 months'}, 'identificationModule': {'nctId': 'NCT03245658', 'briefTitle': 'The Effect of Cannabis in Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effect of Medical Cannabis Inpatients With Palliative Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'H-17000277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THC and CBD Mixture', 'description': '32 patients with palliative pancreatic cancer, intervention with oral drops of THC, 25mg/ml and CBD 50mg/ml, daily administered for 4 weeks', 'interventionNames': ['Drug: THC and CBD Mixture']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '32 patients with palliative pancreatic cancer, no experimental treatment,'}], 'interventions': [{'name': 'THC and CBD Mixture', 'type': 'DRUG', 'otherNames': ['Medical cannabis oral drops'], 'description': 'Individually titrated doses on daily basis', 'armGroupLabels': ['THC and CBD Mixture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4700', 'city': 'Næstved', 'country': 'Denmark', 'facility': 'Department of clinical oncology, Næstved-Roskilde Hospital', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}], 'overallOfficials': [{'name': 'Jens Rikardt Andersen, MD, MPA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Rikardt Andersen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}