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Cabergoline in Nonfunctioning Pituitary Adenomas

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03271918
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
30
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A Single Center, Open Label and Randomized Clinical Trial.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 :
Feb 1, 2015
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

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 Names:
  • dostinex

    		•
    No Intervention: Control Group

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

    Outcome Measures

    Primary Outcome Measures

    1. tumor shrinkage [24 months]

      shrinkage of tumor rest

    Secondary Outcome Measures

    1. Tumor rest stabilization [24 months]

      no evidence of tumor growth with experimental therapy

    Other Outcome Measures

    1. Cardiovascular Safety [24 months]

      Absence of Cardiac Valvar Alterations with Cabergoline Use

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Laboratorio de Investigacoes Medicas 25 São Paulo SP Brazil 01402003

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital

    Investigators

    • Principal Investigator: Rafael L Batista, MD, Instituto do Coracao

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT03271918
    Other Study ID Numbers:
    • 10675
    First Posted:
    Sep 5, 2017
    Last Update Posted:
    Sep 7, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Adenoma
    Pituitary Neoplasms
    Pituitary Diseases
    Cabergoline

    Study Results

    No Results Posted as of Sep 7, 2017