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Cabergoline in Nonfunctioning Pituitary Adenomas

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ClinicalTrials.gov Identifier: NCT03271918
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pituitary Adenoma Nonfunctioning Pituitary Adenoma Drug: Cabergoline Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Single Center, Open Label and Randomized Clinical Trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dopamine Agonist Cabergoline in Residual Clinically Nonfunctioning Pituitary Adenoma After Transphenoidal Surgery: A Single Center, Open Label and Randomized Clinical Trial
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group
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
Other Name: dostinex

No Intervention: Control Group
This group was followed, with clinical visits in same frequency of study group, but without intervention.



Primary Outcome Measures :
  1. tumor shrinkage [ Time Frame: 24 months ]
    shrinkage of tumor rest


Secondary Outcome Measures :
  1. Tumor rest stabilization [ Time Frame: 24 months ]
    no evidence of tumor growth with experimental therapy


Other Outcome Measures:
  1. Cardiovascular Safety [ Time Frame: 24 months ]
    Absence of Cardiac Valvar Alterations with Cabergoline Use



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271918


Locations
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Brazil
Laboratorio de Investigacoes Medicas 25
São Paulo, SP, Brazil, 01402003
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Rafael L Batista, MD Instituto do Coracao

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03271918     History of Changes
Other Study ID Numbers: 10675
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The protocol and statistical analysis plan will be disposable at researchgate site and by e-mail when it will be asked.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: from Aug, 2017 to indefinite
Access Criteria: free
URL: https://www.researchgate.net/home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Sao Paulo General Hospital:
Pituitary Adenoma
Dopaminergic Agonist
Nonfunctioning Pituitary Adenoma
Cabergoline
Additional relevant MeSH terms:
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Adenoma
Cabergoline
Pituitary Neoplasms
Pituitary Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs