Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2026-02-24 @ 7:22 PM
Study NCT ID:
NCT03221920
Status:
UNKNOWN
Last Update Posted:
2017-08-01
First Post:
2017-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Care provider are not told whether the patient belongs to intervention or control group'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomized in to two groups, with very low carbohydrate diet and with normal diet'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-28', 'studyFirstSubmitDate': '2017-07-16', 'studyFirstSubmitQcDate': '2017-07-17', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glasgow Prognostic Score', 'timeFrame': 'Change of baseline Glasgow Prognostic Score on day 21', 'description': 'A score to evaluate systemic inflammation response'}], 'secondaryOutcomes': [{'measure': 'Serum Lactate', 'timeFrame': 'Change of baseline Serum Lactate on day 21', 'description': 'Lactate level in blood serum'}, {'measure': 'TNF Alpha', 'timeFrame': 'Change of baseline TNF Alpha serum level on day 21', 'description': 'Level of Tumor Necrosis Factor Alpha in the blood serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Very Low Carbohydrate Diet', 'Colorectal Adenocarcinoma'], 'conditions': ['Diet Modification', 'Colorectal Adenocarcinoma', 'Systemic Inflammation', 'TNF Alpha', 'Lactate']}, 'referencesModule': {'references': [{'pmid': '18508572', 'type': 'BACKGROUND', 'citation': 'Sethi G, Sung B, Aggarwal BB. TNF: a master switch for inflammation to cancer. Front Biosci. 2008 May 1;13:5094-107. doi: 10.2741/3066.'}, {'pmid': '25460731', 'type': 'BACKGROUND', 'citation': 'Allen BG, Bhatia SK, Anderson CM, Eichenberger-Gilmore JM, Sibenaller ZA, Mapuskar KA, Schoenfeld JD, Buatti JM, Spitz DR, Fath MA. Ketogenic diets as an adjuvant cancer therapy: History and potential mechanism. Redox Biol. 2014;2:963-70. doi: 10.1016/j.redox.2014.08.002. Epub 2014 Aug 7.'}, {'pmid': '27557533', 'type': 'BACKGROUND', 'citation': 'Walenta S, Voelxen NF, Mueller-Klieser W. Lactate-An Integrative Mirror of Cancer Metabolism. Recent Results Cancer Res. 2016;207:23-37. doi: 10.1007/978-3-319-42118-6_2.'}, {'pmid': '27993896', 'type': 'BACKGROUND', 'citation': 'San-Millan I, Brooks GA. Reexamining cancer metabolism: lactate production for carcinogenesis could be the purpose and explanation of the Warburg Effect. Carcinogenesis. 2017 Feb 1;38(2):119-133. doi: 10.1093/carcin/bgw127.'}, {'pmid': '26882261', 'type': 'BACKGROUND', 'citation': 'Lasry A, Zinger A, Ben-Neriah Y. Inflammatory networks underlying colorectal cancer. Nat Immunol. 2016 Mar;17(3):230-40. doi: 10.1038/ni.3384.'}, {'pmid': '24343361', 'type': 'BACKGROUND', 'citation': "Seyfried TN, Flores RE, Poff AM, D'Agostino DP. Cancer as a metabolic disease: implications for novel therapeutics. Carcinogenesis. 2014 Mar;35(3):515-27. doi: 10.1093/carcin/bgt480. Epub 2013 Dec 16."}, {'pmid': '22042432', 'type': 'BACKGROUND', 'citation': 'Venetsanou K, Kaldis V, Kouzanidis N, Papazacharias Ch, Paraskevopoulos J, Baltopoulos G. Measurement of tumour necrosis factor receptors for immune response in colon cancer patients. Clin Exp Med. 2012 Dec;12(4):225-31. doi: 10.1007/s10238-011-0162-5. Epub 2011 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'This study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow Prognostic Score), serum lactate and TNF Alpha levels', 'detailedDescription': 'This study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow Prognostic Score), serum lactate and TNF Alpha levels. The subjects are colorectal adenocarcinoma patients who were decided by experts to be managed by best supportive care. These patients are not deemed to be suitable for surgical intervention , chemotherapy or radiotherapy anymore. The main treatment is supportive. We would like to examined the effect of very low carbohydrate diet on these patients, in which theoretically tumtor cells of the colorectal adenocarcinoma needed glucose to replicate and increases the systemic inflammation response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as colorectal adenocarcinoma pathologically\n* Decided by a digestive surgery consultant to be managed with best supportive care\n* More than 17 years old and capable of making informed consent\n* Karnofsky score \\> 50% or ECOG performance status \\<=2\n* No clinical signs of infection, with one or more of these criteria : fever, leukocytosis, local sign of infection (eg.abscess,ulcer)\n* AST \\< 2 times normal limit\n* ALT \\< 2 times normal limit\n* Serum Creatinine \\< 1,5 times normal limit\n* Not pregnant (for women)\n* Able to understand and willing participate and to sign informed consent form\n* No Diabetes Mellitus\n* No fat intolerance\n* No severe malnutrition or cancer cachexia\n\nExclusion Criteria:\n\n* Patient is still on other therapy for the tumour\n* Patient with coexisting diseases which prohibits the patient to follow the study protocols'}, 'identificationModule': {'nctId': 'NCT03221920', 'briefTitle': 'Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Soetomo General Hospital'}, 'officialTitle': 'Effect of Very Low Carbohydrate Diet to Glasgow Prognostic Score, Serum Lactate and TNF Alpha on Colorectal Cancer Patients With Best Supportive Care', 'orgStudyIdInfo': {'id': 'DrSoetomoGH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Very Low Carbohydrate Diet', 'description': 'The patient will be evaluated for baseline clinical and laboratory values, and counselled on very low carbohydrate diet.', 'interventionNames': ['Other: Very Low Carbohydrate Diet']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The patient will be evaluated for baseline clinical and laboratory values, and counselled on normal healthy .'}], 'interventions': [{'name': 'Very Low Carbohydrate Diet', 'type': 'OTHER', 'description': '1 : 4 ratio of carbohydrate to fat of the total daily calories intake', 'armGroupLabels': ['Very Low Carbohydrate Diet']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vicky S Budipramana, PhD', 'role': 'CONTACT', 'email': 'vickysbudi@gmail.com', 'phone': '0811315812'}, {'name': 'Fransiscus Arifin, MD', 'role': 'CONTACT', 'email': 'farifin@gmail.com'}], 'overallOfficials': [{'name': 'Vicky S Budipramana, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RS Dr Sutomo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Soetomo General Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}