Cabergoline in Nonfunctioning Pituitary Adenomas

September 4, 2017 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01402003
        • Laboratorio de Investigacoes Medicas 25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor shrinkage
Time Frame: 24 months
shrinkage of tumor rest
24 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Safety
Time Frame: 24 months
Absence of Cardiac Valvar Alterations with Cabergoline Use
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 7, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10675 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The protocol and statistical analysis plan will be disposable at researchgate site and by e-mail when it will be asked.

IPD Sharing Time Frame

from Aug, 2017 to indefinite

IPD Sharing Access Criteria

free

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pituitary Adenoma

Clinical Trials on Cabergoline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe