Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-08 @ 4:43 PM
Study NCT ID:
NCT01396733
Status:
WITHDRAWN
Last Update Posted:
2021-07-23
First Post:
2011-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2011-07-18', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increment of radioactive iodine uptake', 'timeFrame': '3months after alpha-lipoic acid treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['thyroid', 'cancer', 'redifferentiation', 'lipoic acid'], 'conditions': ['Thyroid', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Radioiodine (I-131) therapy is of proven efficacy for treatment of differentiated thyroid carcinoma (DTC). However, loss of differentiation in recurrent or metastatic DTC which decrease I-131 uptake may decrease the efficacy of I-131 therapy. Therefore, strategies to improve I-131 uptake are mandatory. This study is an open label clinical study to evaluate the effectiveness of alpha-lipoic acid (ALA) for improving I-131 uptake in recurrent or metastatic of DTC with defective I-131 uptake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 20 to 75 years\n2. under birth control, if fertile women\n3. Groups\n\n * who received radioactive iodine treatment for recurrent and metastatic thyroid cancer, and did not showed any uptake at post-therapeutic whole body scan\n * who planned to receive empirical radioactive treatment due to high expected recurrence\n\nExclusion Criteria:\n\n* allergic to alpha-lipoic acid\n* severe heart failure, lung disease, or end-stage renal disease\n* liver function abnormalities (x2.5 above normal limits)\n* neuropsychologically unstable patients\n* previous history of drug medication such as oral steroid, digoxin, theophylline, carbamazepine, valproic acid, phenobarbital, methotrexate, cyclosporin, tacrolimus within 3 months before this recruitment.\n* who is already taking alpha-lipoic acid for other purpose.'}, 'identificationModule': {'nctId': 'NCT01396733', 'acronym': 'RALT', 'briefTitle': 'Redifferentiation Therapy Using Alpha Lipoic Acid in Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Clinical Trial to Evaluate Efficacy of Redifferentiation Therapy Using Alpha-lipoic Acid in Thyroid Cancer Patients With Decreased Radioactive Iodine Uptake', 'orgStudyIdInfo': {'id': 'AMC_THY_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose group', 'description': 'Patients who will receive 600 mg/day alpha-lipoic acid', 'interventionNames': ['Drug: alpha-lipoic acids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose group', 'description': 'Patients who will receive 1,200 mg/day alpha-lipoic acid', 'interventionNames': ['Drug: alpha-lipoic acids']}], 'interventions': [{'name': 'alpha-lipoic acids', 'type': 'DRUG', 'description': 'alpha-lipoic acid 600 mg/day or 1,200 mg/day 600 mg/day - Three tablets (200mg x 3), one time per day for 3 months 1,200 mg/day - Three tablets (200mg x 3), two times per day for 3 months', 'armGroupLabels': ['High dose group', 'Low dose group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Won Bae Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}