Cabergoline in Nonfunctioning Pituitary Adenomas

Phase 3

Completed

• Conditions: Nonfunctioning Pituitary Adenoma; Pituitary Adenoma
• Interventions: Drug: Cabergoline

• Registration Number: NCT03271918
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Study Timeline

• Study Start: 2015-02-01
• Primary Completion: 2017-02-01
• Status Verified: 2017-08
• Study Completion: 2017-08-01
• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-08-31
• Last Update Submitted: 2017-09-04
• Study First Posted: 2017-09-05
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• presence of pituitary tumor rest at 6 months after neurosurgery
• absence of previous hormonal pituitary hypersecretion
• absence of previous radiotherapy and/or radiosurgery
• Histopathological exam showing pituitary adenoma

Exclusion Criteria

• ACTH immunoexpression at histopathological exam
• presence of previous radiotherapy and/or radio surgery
• psychotic psychiatric disease
• moderate or severe alterations in cardiac valves

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Cabergoline	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.

Primary Outcome Measures

Name	Time	Method
tumor shrinkage	24 months	shrinkage of tumor rest

Secondary Outcome Measures

Name	Time	Method
Tumor rest stabilization	24 months	no evidence of tumor growth with experimental therapy

Trial Locations

Locations (1)

Laboratorio de Investigacoes Medicas 25; 🇧🇷 São Paulo, SP, Brazil