Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-29 @ 3:59 AM
Study NCT ID:
NCT00757094
Status:
COMPLETED
Last Update Posted:
2010-02-25
First Post:
2008-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of Fasting While Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-24', 'studyFirstSubmitDate': '2008-09-19', 'studyFirstSubmitQcDate': '2008-09-19', 'lastUpdatePostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of fasting while receiving chemotherapy', 'timeFrame': 'two months'}], 'secondaryOutcomes': [{'measure': 'Effect of fasting on chemotherapy side effects', 'timeFrame': 'two months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fasting', 'Chemotherapy', 'Cancer'], 'conditions': ['Fasting', 'Chemotherapy', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '18378900', 'type': 'BACKGROUND', 'citation': 'Raffaghello L, Lee C, Safdie FM, Wei M, Madia F, Bianchi G, Longo VD. Starvation-dependent differential stress resistance protects normal but not cancer cells against high-dose chemotherapy. Proc Natl Acad Sci U S A. 2008 Jun 17;105(24):8215-20. doi: 10.1073/pnas.0708100105. Epub 2008 Mar 31.'}, {'pmid': '7063854', 'type': 'BACKGROUND', 'citation': 'Weindruch R, Walford RL. Dietary restriction in mice beginning at 1 year of age: effect on life-span and spontaneous cancer incidence. Science. 1982 Mar 12;215(4538):1415-8. doi: 10.1126/science.7063854.'}, {'pmid': '4330798', 'type': 'BACKGROUND', 'citation': 'Ross MH, Bras G. Lasting influence of early caloric restriction on prevalence of neoplasms in the rat. J Natl Cancer Inst. 1971 Nov;47(5):1095-113. No abstract available.'}, {'pmid': '2497075', 'type': 'BACKGROUND', 'citation': 'Klurfeld DM, Welch CB, Lloyd LM, Kritchevsky D. Inhibition of DMBA-induced mammary tumorigenesis by caloric restriction in rats fed high-fat diets. Int J Cancer. 1989 May 15;43(5):922-5. doi: 10.1002/ijc.2910430532.'}, {'pmid': '12866038', 'type': 'BACKGROUND', 'citation': 'Dirx MJ, Zeegers MP, Dagnelie PC, van den Bogaard T, van den Brandt PA. Energy restriction and the risk of spontaneous mammary tumors in mice: a meta-analysis. Int J Cancer. 2003 Sep 20;106(5):766-70. doi: 10.1002/ijc.11277.'}]}, 'descriptionModule': {'briefSummary': 'Fasting (refraining from eating and drinking) during the day is safe while receiving chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fasting patients who are schedulled to receive chemotherapy during the month of Ramadan', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Established diagnosis of cancer\n* Signed informed consent\n* Adequate CBC and chemistry to receive chemotherapy\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00757094', 'briefTitle': 'Safety and Feasibility of Fasting While Receiving Chemotherapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'King Fahad Medical City'}, 'officialTitle': 'Safety and Feasibility of Fasting While Receiving Chemotherapy', 'orgStudyIdInfo': {'id': 'KFMC IRB-08-040'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'I', 'description': 'Patients planning to observe fasting while receiving chemotherapy during the month of Ramadan'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11525', 'city': 'Riyadh', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'King Fahad Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Ali SM Al-Shanqeeti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Fahad Medical City'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Fahad Medical City', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Ali Al-Shanqeeti', 'oldOrganization': 'King Fahad Medical City'}}}}