Cabergoline in Nonfunctioning Pituitary Adenomas

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pituitary Adenoma, Nonfunctioning Pituitary Adenoma

Intervention / Treatment
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* Drug: Cabergoline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Single Center, Open Label and Randomized Clinical Trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>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. | Drug: Cabergoline<br> <br> * Other names: dostinex;|
| No Intervention: Control Group<br>This group was followed, with clinical visits in same frequency of study group, but without intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor shrinkage | shrinkage of tumor rest | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor rest stabilization | no evidence of tumor growth with experimental therapy | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pituitary Adenoma, Dopaminergic Agonist, Nonfunctioning Pituitary Adenoma, Cabergoline