Cabergoline in Nonfunctioning Pituitary Adenomas

Pituitary Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271918
• Other study ID #: 10675
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2017
• Last updated: September 4, 2017
• Start date: February 1, 2015
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Nonfunctioning Pituitary Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Drug:
• Cabergoline

Locations

Country	Name	City	State
Brazil	Laboratorio de Investigacoes Medicas 25	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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 — View 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. Cl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular Safety	Absence of Cardiac Valvar Alterations with Cabergoline Use	24 months
Primary	tumor shrinkage	shrinkage of tumor rest	24 months
Secondary	Tumor rest stabilization	no evidence of tumor growth with experimental therapy	24 months