NCT03271918

Cabergoline in Nonfunctioning Pituitary Adenomas

Dopamine Agonist Cabergoline in Residual Clinically Nonfunctioning Pituitary Adenoma After Transphenoidal Surgery: A Single Center, Open Label and Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Pituitary Adenoma
• Nonfunctioning Pituitary Adenoma

Interventions

Type	Name	Description
DRUG	Cabergoline

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-02-01
• Completion: 2017-08-01
• First posted: 2017-09-05
• Last updated: 2017-09-07

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study