Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT00079794
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2004-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iscar for Supplemental Care in Stage IV Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-23', 'studyFirstSubmitDate': '2004-03-15', 'studyFirstSubmitQcDate': '2004-03-15', 'lastUpdatePostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['lung cancer', 'herbal medicine', 'non-small cell cancer', 'Iscar', 'mistletoe'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study it to determine whether supplemental treatment with Iscar improves immune function and quality of life among Stage IV non-small cell lung carcinoma patients receiving conventional chemotherapy. Iscar is an herbal medicine made from the total plant extract of mistletoe. this preparation is already in use in Europe and its use in the US is likely to increase as cancer patients continue to seek alternative therapies.', 'detailedDescription': 'See Brief Summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage IV NSCLC patients who receive standard chemotherapy\n\nExclusion criteria:\n\n* Known allergy to Viscum Album L.\n* Concomitant use of other mistletoe products\n* Concomitant use of mushroom glucan and proteoglycan extracts\n* Concomitant use of thymus extract products\n* Inability to self-report quality of life utilizing assessment tools\n* Ongoing steroid or ACTH therapy\n* Co-morbid immunocompromised state\n* Pregnancy\n* Participation in other clinical trials'}, 'identificationModule': {'nctId': 'NCT00079794', 'briefTitle': 'Iscar for Supplemental Care in Stage IV Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Iscar for Supplemental Care in Stage IV Lung Cancer', 'orgStudyIdInfo': {'id': 'R21AT001020-01', 'link': 'https://reporter.nih.gov/quickSearch/R21AT001020-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'Rosenzweig'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Iscar', 'type': 'DRUG'}, {'name': 'mistletoe', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Steven Rosenzweig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jefferson Medical College of Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}