Cabergoline in Nonfunctioning Pituitary Adenomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03271918|
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : September 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pituitary Adenoma Nonfunctioning Pituitary Adenoma||Drug: Cabergoline||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A Single Center, Open Label and Randomized Clinical Trial.|
|Masking:||None (Open Label)|
|Official Title:||Dopamine Agonist Cabergoline in Residual Clinically Nonfunctioning Pituitary Adenoma After Transphenoidal Surgery: A Single Center, Open Label and Randomized Clinical Trial|
|Actual Study Start Date :||February 1, 2015|
|Actual Primary Completion Date :||February 1, 2017|
|Actual Study Completion Date :||August 1, 2017|
Experimental: Study Group
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.
Other Name: dostinex
No Intervention: Control Group
This group was followed, with clinical visits in same frequency of study group, but without intervention.
- tumor shrinkage [ Time Frame: 24 months ]shrinkage of tumor rest
- Tumor rest stabilization [ Time Frame: 24 months ]no evidence of tumor growth with experimental therapy
- Cardiovascular Safety [ Time Frame: 24 months ]Absence of Cardiac Valvar Alterations with Cabergoline Use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271918
|Laboratorio de Investigacoes Medicas 25|
|São Paulo, SP, Brazil, 01402003|
|Principal Investigator:||Rafael L Batista, MD||Instituto do Coracao|