Cabergoline in Nonfunctioning Pituitary Adenomas

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 3

Conditions: Pituitary Adenoma; Nonfunctioning Pituitary Adenoma

Treatments: Drug: Cabergoline

Study type: Interventional

Funder types: Other

Identifiers

NCT03271918

10675 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Study Group

Experimental group

Description:

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.

Treatment:

Drug: Cabergoline

Control Group

No Intervention group

Description:

This group was followed, with clinical visits in same frequency of study group, but without intervention.