Laboratorio de Investigacoes Medicas 25
São Paulo, 01402003, Brazil
NCT Number: NCT03271918
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 3
São Paulo, 01402003, Brazil
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.
Transsphenoidal 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.
Since 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.
In 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: dostinex
Time frame: 24 months
shrinkage of tumor rest
Time frame: 24 months
no evidence of tumor growth with experimental therapy
Time frame: 24 months
Absence of Cardiac Valvar Alterations with Cabergoline Use
University of Sao Paulo General Hospital
Other
Dopamine Agonist Cabergoline in Residual Clinically Nonfunctioning Pituitary Adenoma After Transphenoidal Surgery: A Single Center, Open Label and Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00001452
Abnormalities, Multiple, Adrenal Gland Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT02750371
Brain Diseases, Brain Neoplasms
Bordeaux, France
View Trial DetailsNCT07247526
Anxiety Disorders, Brain Diseases
Edirne, Turkey (Türkiye)
View Trial DetailsNCT06826170
Brain Diseases, Brain Neoplasms
Milan, Italy
View Trial Details