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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03271918
Enrollment
140
Registered
2017-09-05
Start date
2015-02-01
Completion date
2017-08-01
Last updated
2017-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonfunctioning Pituitary Adenoma, Pituitary Adenoma

Keywords

Pituitary Adenoma, Dopaminergic Agonist, Nonfunctioning Pituitary Adenoma, Cabergoline

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.

Interventions

DRUGCabergoline

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A Single Center, Open Label and Randomized Clinical Trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
tumor shrinkage24 monthsshrinkage of tumor rest

Secondary

MeasureTime frameDescription
Tumor rest stabilization24 monthsno evidence of tumor growth with experimental therapy

Other

MeasureTime frameDescription
Cardiovascular Safety24 monthsAbsence of Cardiac Valvar Alterations with Cabergoline Use

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026