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Trial record 26 of 301 for:    Recruiting, Not yet recruiting, Available Studies | "Adenoma"

Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas

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ClinicalTrials.gov Identifier: NCT02288962
Recruitment Status : Recruiting
First Posted : November 13, 2014
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:

Due to lack of hormone overproduction in non-functioning pituitary adenomas (NFPAs), only the symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near future will undergo pituitary surgery. The remaining adenomas are monitored regularly. Operation of these large adenomas will rarely remove all tumour tissue, and there is also a risk of worsening of pituitary function. Often, adenomas with the highest growth potential are operated several times and some also need radiation therapy, providing additional risk for pituitary failure. Unlike some of the hormone-producing adenomas, there is no established pharmacological treatment for NFPAs. However, there are a few non-randomized studies suggesting that treatment with dopamine agonists may slow growth, and also induce tumour shrinkage. At present, cabergoline is the dopamine agonist most widely used in the treatment of pituitary adenomas secreting prolactin.

Aim is to study the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on the change in tumour volume.


Condition or disease Intervention/treatment Phase
Pituitary Neoplasms Adenoma Drug: cabergoline Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas (NFPAs) - a Randomized Controlled Trial
Actual Study Start Date : November 2014
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2025


Arm Intervention/treatment
Experimental: cabergoline

Target dose for cabergoline is 2 mg/week.The medication is administered in the evening to minimize side effects. If intolerable side effects occur despite this, it may be necessary to treat with a lower dose than 2 mg per week.

Treatment scheme: 0.5 mg x 1 per week the first 2 weeks, then 0.5 mg x 2 per week the next 2 weeks, then 1 + 0.5 mg per week the next 2 weeks, then 1 mg x 2 per week (target dose) for the rest of the study

Drug: cabergoline
Other Names:
  • galastop
  • FCE 21336
  • Cabaser
  • Dostinex
  • Cabaseril
  • cabergoline diphosphate

No Intervention: observation
visits and controls as usual



Primary Outcome Measures :
  1. change in tumour volume during the main study of two years [ Time Frame: 2 years ]
    This includes the percentage and absolute change in tumour volume, but also the number of patients with significant tumour shrinkage or tumour growth (defined by ≥ 10 % or ≥ 2 mm shrinkage/growth in at least one dimension)


Secondary Outcome Measures :
  1. need for surgical and/or radiation treatment [ Time Frame: up till 2 years ]
  2. changed pituitary function [ Time Frame: up till 2 years ]
    measured by analysis of blood tests, basal and stimulation tests

  3. change in tumour's distance to chiasma opticum in mm [ Time Frame: up till 2 years ]
    as measured by analysis of MRI images

  4. development of cardiac valvulopathy [ Time Frame: up till 2 years ]
    as measured by analysis of echo cardiography

  5. impulse control disorder [ Time Frame: up till 2 years ]
    as measured by questionnaire visual files: clinical evaluation by ophthalmologist and perimetry



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A previously untreated non-functioning pituitary macroadenoma (largest diameter ≥ 10 mm) with either demonstrated growth on repeated MRI scans or ≤ 2 mm distance to chiasma opticum, or:
  • a residual non-functioning pituitary adenoma after surgery (largest diameter ≥ 5 mm) that is either extrasellar and/or with documented growth after surgical treatment of a non-functioning pituitary macroadenoma

Exclusion Criteria:

  • Clear indication for surgery at the time of inclusion
  • Previous radiation therapy
  • Pituitary surgery the last 6 months
  • Previous apoplexy/bleeding in the adenoma
  • Pregnancy or lactation
  • Contraindications for cabergoline treatment (Known cardiac valvular disease, known pulmonal, pericardial or retroperitoneal fibrosis, clinical significant liver insufficiency, use of medications that interact with cabergoline
  • unfit to participate due to any other reason

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): NCT02288962


Contacts
Contact: Stine L Fougner, md phd stine.fougner@ntnu.no
Contact: Sven M Carlsen, md phd sven.carlsen@ntnu.no

Locations
Norway
Department of Endocrinology, Akershus University hospital Recruiting
Oslo, Norway
Department of Endocrinology, St. Olavs Hospital Recruiting
Trondheim, Norway, 7006
Contact: Stine L Fougner, MD PhD       stine.fougner@ntnu.no   
Sweden
Sahlgrenska University Hospital Recruiting
Gøteborg, Sweden
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Principal Investigator: Sven M Carlsen, prof md Norwegian University of Science and Technology

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02288962     History of Changes
Other Study ID Numbers: 2012/677
2012-001338-32 ( EudraCT Number )
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Olavs Hospital:
dopamine agonists
cabergoline

Additional relevant MeSH terms:
Adenoma
Pituitary Diseases
Pituitary Neoplasms
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
Dopamine
Dopamine Agents
Cabergoline
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents