NCT03271918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
Last Updated

September 7, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

August 31, 2017

Last Update Submit

September 4, 2017

Conditions

Pituitary AdenomaNonfunctioning Pituitary Adenoma

Keywords

Pituitary AdenomaDopaminergic AgonistNonfunctioning Pituitary AdenomaCabergoline

Outcome Measures

Primary Outcomes (1)

  • tumor shrinkage

    shrinkage of tumor rest

    24 months

Secondary Outcomes (1)

  • Tumor rest stabilization

    24 months

Other Outcomes (1)

  • Cardiovascular Safety

    24 months

Study Arms (2)

Study Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

CabergolineDRUG
Also known as: dostinex
Study Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • ACTH immunoexpression at histopathological exam
  • presence of previous radiotherapy and/or radio surgery
  • psychotic psychiatric disease
  • moderate or severe alterations in cardiac valves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorio de Investigacoes Medicas 25

São Paulo, São Paulo, 01402003, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 25418156RESULT

  • 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.

    PMID: 27150495RESULT

  • Dong W, Shi W, Liu Y, Li J, Zhang Y, Dong G, Dong X, Gao H. CHST7 Methylation Status Related to the Proliferation and Differentiation of Pituitary Adenomas. Cells. 2022 Aug 4;11(15):2400. doi: 10.3390/cells11152400.

    PMID: 35954244DERIVED

  • 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.

    PMID: 30540568DERIVED

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Rafael L Batista, MD

    Instituto do Coracao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Single Center, Open Label and Randomized Clinical Trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 5, 2017

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

August 1, 2017

Last Updated

September 7, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
from Aug, 2017 to indefinite
Access Criteria
free
More information

Locations

BR(1)