Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT03271918
Status:
COMPLETED
Last Update Posted:
2017-09-07
First Post:
2017-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cabergoline in Nonfunctioning Pituitary Adenomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077465', 'term': 'Cabergoline'}], 'ancestors': [{'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Single Center, Open Label and Randomized Clinical Trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-04', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiovascular Safety', 'timeFrame': '24 months', 'description': 'Absence of Cardiac Valvar Alterations with Cabergoline Use'}], 'primaryOutcomes': [{'measure': 'tumor shrinkage', 'timeFrame': '24 months', 'description': 'shrinkage of tumor rest'}], 'secondaryOutcomes': [{'measure': 'Tumor rest stabilization', 'timeFrame': '24 months', 'description': 'no evidence of tumor growth with experimental therapy'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pituitary Adenoma', 'Dopaminergic Agonist', 'Nonfunctioning Pituitary Adenoma', 'Cabergoline'], 'conditions': ['Pituitary Adenoma', 'Nonfunctioning Pituitary Adenoma']}, 'referencesModule': {'references': [{'pmid': '25418156', 'type': 'RESULT', 'citation': 'Vieira Neto L, Wildemberg LE, Moraes AB, Colli LM, Kasuki L, Marques NV, Gasparetto EL, de Castro M, Takiya CM, Gadelha MR. Dopamine receptor subtype 2 expression profile in nonfunctioning pituitary adenomas and in vivo response to cabergoline therapy. Clin Endocrinol (Oxf). 2015 May;82(5):739-46. doi: 10.1111/cen.12684. Epub 2015 Jan 8.'}, {'pmid': '27150495', 'type': 'RESULT', 'citation': 'Greenman Y, Cooper O, Yaish I, Robenshtok E, Sagiv N, Jonas-Kimchi T, Yuan X, Gertych A, Shimon I, Ram Z, Melmed S, Stern N. Treatment of clinically nonfunctioning pituitary adenomas with dopamine agonists. Eur J Endocrinol. 2016 Jul;175(1):63-72. doi: 10.1530/EJE-16-0206. Epub 2016 May 5.'}, {'pmid': '35954244', 'type': 'DERIVED', 'citation': 'Dong W, Shi W, Liu Y, Li J, Zhang Y, Dong G, Dong X, Gao H. CHST7 Methylation Status Related to the Proliferation and Differentiation of Pituitary Adenomas. Cells. 2022 Aug 4;11(15):2400. doi: 10.3390/cells11152400.'}, {'pmid': '30540568', 'type': 'DERIVED', 'citation': 'Batista RL, Musolino NRC, Cescato VAS, da Silva GO, Medeiros RSS, Herkenhoff CGB, Trarbach EB, Cunha-Neto MB. Cabergoline in the Management of Residual Nonfunctioning Pituitary Adenoma: A Single-Center, Open-Label, 2-Year Randomized Clinical Trial. Am J Clin Oncol. 2019 Feb;42(2):221-227. doi: 10.1097/COC.0000000000000505.'}]}, 'descriptionModule': {'briefSummary': 'Clinically nonfunctioning pituitary adenoma remains the only pituitary tumor subtype for which no effective medical therapy is available or recommended. We will evaluate the use of cabergoline in a clinical trial, in order to define the efficacy of this treatment in nonfunctioning pituitary adenoma.', 'detailedDescription': 'Nonfunctioning pituitary adenomas (NFPA) are common tumors of sellar region characterized by the absence of clinically hormonal pituitary secretion. These adenomas are typically not diagnosed until they become very large and cause compressive neurologic symptons (e.g. visual impairment or cranial nerve palsy). Most of them are able to synthesized gonadotropins but not secreted it.\n\nTranssphenoidal surgical resection is the first-choice therapy in NFPA. However, complete removal is difficult and tumor rest is very common. In these cases, the pragmatic use of radiotherapy is effective to reduce residual tumor growth or recurrence, but it is related with severe side effects. Another possibility is the clinical observation, or wait-to-see approach, but it is associated with tumor progression: 40% in 5-10 years. The efficacy of some medical treatment are not defined yet.\n\nSince the identification of dopaminergic and somatostatinergic receptors in NFPA, the pharmacological treatment of the NFPA has been considered as a possibility for treatment. To date, clinical use of dopamine agonist (DA) in NFPA patients has been evaluated in some studies. However, these studies present modest and inconclusive results and the DA role in the NPFA management remains undefined.\n\nIn this study, the investigators plan a clinical trial designed to investigate the efficacy of cabergoline in NFPA individuals with remaining tumor after primary neurosurgery. These results could help to define the efficacy of DA in NFPA management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of pituitary tumor rest at 6 months after neurosurgery\n* absence of previous hormonal pituitary hypersecretion\n* absence of previous radiotherapy and/or radiosurgery\n* Histopathological exam showing pituitary adenoma\n\nExclusion Criteria:\n\n* ACTH immunoexpression at histopathological exam\n* presence of previous radiotherapy and/or radio surgery\n* psychotic psychiatric disease\n* moderate or severe alterations in cardiac valves'}, 'identificationModule': {'nctId': 'NCT03271918', 'briefTitle': 'Cabergoline in Nonfunctioning Pituitary Adenomas', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Dopamine Agonist Cabergoline in Residual Clinically Nonfunctioning Pituitary Adenoma After Transphenoidal Surgery: A Single Center, Open Label and Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '10675'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'This group received cabergoline, in a total week dose of 3.5 mg, starting 6 months after transphenoidal surgical approach with evidence of tumoral rest in MRI and pituitary adenoma hystopathological confirmation.', 'interventionNames': ['Drug: Cabergoline']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'This group was followed, with clinical visits in same frequency of study group, but without intervention.'}], 'interventions': [{'name': 'Cabergoline', 'type': 'DRUG', 'otherNames': ['dostinex'], 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01402003', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Laboratorio de Investigacoes Medicas 25', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Rafael L Batista, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto do Coracao'}]}, 'ipdSharingStatementModule': {'url': 'https://www.researchgate.net/home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'from Aug, 2017 to indefinite', 'ipdSharing': 'YES', 'description': 'The protocol and statistical analysis plan will be disposable at researchgate site and by e-mail when it will be asked.', 'accessCriteria': 'free'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}