Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT00223158
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2005-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014284', 'term': 'Triiodothyronine'}], 'ancestors': [{'id': 'D013970', 'term': 'Thyronines'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-07', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-08', 'studyFirstSubmitDate': '2005-09-19', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the hypothyroid status by the Billewicz questionnaire.'}], 'secondaryOutcomes': [{'measure': 'The time to reach an acceptable TSH elevation.'}]}, 'conditionsModule': {'keywords': ['Thyroid cancer', 'Hypothyroidism', 'Whole Body Scintigraphy', 'Liothyronine', 'TSH elevation'], 'conditions': ['Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'To compare the hypothyroid state in patients with thyroid cancer prepared either by placebo or L-T3 following L-T4 withdrawal in preparation for whole body scintigraphy. To evaluate the time needed for TSH elevation (\\> 30 mUI/L) on placebo vs. L-T3.', 'detailedDescription': "Patients with well differentiated thyroid cancer (DTC) need whole-body scintigraphy (WBS) and thyroglobulin (Tg) measurement in order to detect recurrence. Classically, withdrawal from levothyroxine (L-T4) during 4-6 weeks is needed for TSH elevation (\\> 30mUI/L), to allow iodine uptake and Tg production. As a result, patients become hypothyroid with impaired quality of life and a potential for tumour flare-up. Recombinant hTSH before WBS prevents hypothyroidism but is not yet approved for radioiodine treatment and is an expensive therapy. L-T3 substitution during the first 2-3 weeks of withdrawal is an alternative used empirically to prepare patients; however, no data exists to prove its benefit upon reducing hypothyroidism.\n\nObjectives: 1) To compare the hypothyroid state in patients prepared either by placebo or L-T3 following L-T4 withdrawal. 2) To evaluate the time needed for TSH elevation (\\> 30 mUI/L) on placebo vs. L-T3.\n\nMethod: At the time of L-T4 withdrawal or after thyroidectomy, patients with DTC awaiting WBS or radioiodine treatment were randomized in two groups (double-blind): L-T3 (50 mg qd) or an identical placebo for 3 weeks, after which treatment was stopped for 2 weeks. A validated questionnaire of signs and symptoms of hypothyroidism (Billewicz's scale) was administered every 2 weeks until the WBS. TSH, fT4 and fT3 were measured weekly."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with well-differentiated thyroid cancer, with total thyroidectomy\n* 18 y.o. or older\n\nExclusion Criteria:\n\n* Use of rhTSH for Whole Body Scintigraphy preparation\n* Non stable cardiac arrythmias\n* Any condition impairing TSH elevation(glucocorticoid use, hypopituitarism)\n* Allergy to Liothyronine\n* Inability to give a consent'}, 'identificationModule': {'nctId': 'NCT00223158', 'briefTitle': 'Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CRC 03-52-R1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Liothyronine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Rébecca Leboeuf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}, {'name': 'Marie-France Langlois, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}, {'name': 'Patrice Perron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}, {'name': 'André Carpentier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}, {'name': 'Jean Verreault, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patrice Perron', 'class': 'OTHER'}, 'collaborators': [{'name': 'Theramed co.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Patrice Perron', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}