Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-18 @ 8:39 AM
Study NCT ID:
NCT00861432
Status:
COMPLETED
Last Update Posted:
2016-09-13
First Post:
2009-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Questionnaires of Tumor Patients With and Without Additive Homeopathic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2009-03-12', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference with regard to subjective feeling and life quality with or without homeopathic treatment', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Life quality', 'questionnaire', 'tumor patients'], 'conditions': ['Tumor']}, 'referencesModule': {'references': [{'pmid': '26051564', 'type': 'DERIVED', 'citation': 'Frass M, Friehs H, Thallinger C, Sohal NK, Marosi C, Muchitsch I, Gaertner K, Gleiss A, Schuster E, Oberbaum M. Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial. Complement Ther Med. 2015 Jun;23(3):309-17. doi: 10.1016/j.ctim.2015.03.004. Epub 2015 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'Tumor patients receiving conventional tumor therapies are included into this study. The patients are randomized into two groups receiving either additive homeopathic therapy or not. Two questionnaires referring to subjective feeling and life quality are filled out by the patients with each visit to the outpatients Department. One of them is the QLQC30 questionnaire of the EORTC. The results of the questionnaires of the two groups are compared.', 'detailedDescription': 'Quality of life is an important issue for cancer patients, especially during the periods of chemotherapy and radiation. Preliminary results have revealed positive effects of add-on homeopathy on quality of life as well as subjective well-being. Patients are receiving classical homeopathy with administration of either globules and/or dilutions. With each appointment, patients complete two questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTumor patients between 18 and 100 years old\n\nExclusion criteria: Patients younger than 18 years, patients having completed less than 3 questionnaires.'}, 'identificationModule': {'nctId': 'NCT00861432', 'briefTitle': 'Evaluation of Questionnaires of Tumor Patients With and Without Additive Homeopathic Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Evaluation of Quality of Life of Tumor Patients With and Without Additive Homeopathy.', 'orgStudyIdInfo': {'id': '2341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'additive homeopathic treatment', 'description': 'These patients receive additive homeopathic treatment during conventional cancer treatment.', 'interventionNames': ['Other: additive homeopathic treatment']}, {'type': 'NO_INTERVENTION', 'label': 'no additive homeopathic treatment', 'description': 'These patients do not receive additive homeopathic treatment during conventional cancer treatment.'}], 'interventions': [{'name': 'additive homeopathic treatment', 'type': 'OTHER', 'otherNames': ['homeopathic remedies according to the Pharmacopoeia'], 'description': 'These patients receive additive homeopathic treatment', 'armGroupLabels': ['additive homeopathic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Med. Univ. Vienna, Dept. Internal Med. I', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Michael Frass, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Michael Frass', 'investigatorAffiliation': 'Medical University of Vienna'}}}}