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Cabergoline in Nonfunctioning Pituitary Adenomas

Primary Purpose

Pituitary Adenoma, Nonfunctioning Pituitary Adenoma

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Cabergoline
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Adenoma focused on measuring Pituitary Adenoma, Dopaminergic Agonist, Nonfunctioning Pituitary Adenoma, Cabergoline

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Laboratorio de Investigacoes Medicas 25

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

tumor shrinkage
shrinkage of tumor rest

Secondary Outcome Measures

Tumor rest stabilization
no evidence of tumor growth with experimental therapy

Full Information

First Posted
August 31, 2017
Last Updated
September 4, 2017
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03271918
Brief Title
Cabergoline in Nonfunctioning Pituitary Adenomas
Official Title
Dopamine Agonist Cabergoline in Residual Clinically Nonfunctioning Pituitary Adenoma After Transphenoidal Surgery: A Single Center, Open Label and Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma, Nonfunctioning Pituitary Adenoma
Keywords
Pituitary Adenoma, Dopaminergic Agonist, Nonfunctioning Pituitary Adenoma, Cabergoline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A Single Center, Open Label and Randomized Clinical Trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group was followed, with clinical visits in same frequency of study group, but without intervention.
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Other Intervention Name(s)
dostinex
Primary Outcome Measure Information:
Title
tumor shrinkage
Description
shrinkage of tumor rest
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Tumor rest stabilization
Description
no evidence of tumor growth with experimental therapy
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Cardiovascular Safety
Description
Absence of Cardiac Valvar Alterations with Cabergoline Use
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael L Batista, MD
Organizational Affiliation
Instituto do Coracao
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratorio de Investigacoes Medicas 25
City
São Paulo
State/Province
SP
ZIP/Postal Code
01402003
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.researchgate.net/home
Citations:
PubMed Identifier
25418156
Citation
Vieira Neto L, Wildemberg LE, Moraes AB, Colli LM, Kasuki L, Marques NV, Gasparetto EL, de Castro M, Takiya CM, Gadelha MR. Dopamine receptor subtype 2 expression profile in nonfunctioning pituitary adenomas and in vivo response to cabergoline therapy. Clin Endocrinol (Oxf). 2015 May;82(5):739-46. doi: 10.1111/cen.12684. Epub 2015 Jan 8.
Results Reference
result
PubMed Identifier
27150495
Citation
Greenman Y, Cooper O, Yaish I, Robenshtok E, Sagiv N, Jonas-Kimchi T, Yuan X, Gertych A, Shimon I, Ram Z, Melmed S, Stern N. Treatment of clinically nonfunctioning pituitary adenomas with dopamine agonists. Eur J Endocrinol. 2016 Jul;175(1):63-72. doi: 10.1530/EJE-16-0206. Epub 2016 May 5.
Results Reference
result
PubMed Identifier
30540568
Citation
Batista RL, Musolino NRC, Cescato VAS, da Silva GO, Medeiros RSS, Herkenhoff CGB, Trarbach EB, Cunha-Neto MB. Cabergoline in the Management of Residual Nonfunctioning Pituitary Adenoma: A Single-Center, Open-Label, 2-Year Randomized Clinical Trial. Am J Clin Oncol. 2019 Feb;42(2):221-227. doi: 10.1097/COC.0000000000000505.
Results Reference
derived

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Cabergoline in Nonfunctioning Pituitary Adenomas

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