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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Department of Endocrinology, Akershus University hospital
Oslo, Norway
Department of Endocrinology, St. Olavs Hospital
Trondheim, Norway
Sahlgrenska University Hospital
Gothenburg, Sweden
change in tumour volume during the main study of two 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)
Time frame: 2 years
need for surgical and/or radiation treatment
Time frame: up till 2 years
changed pituitary function
measured by analysis of blood tests, basal and stimulation tests
Time frame: up till 2 years
change in tumour's distance to chiasma opticum in mm
as measured by analysis of MRI images
Time frame: up till 2 years
development of cardiac valvulopathy
as measured by analysis of echo cardiography
Time frame: up till 2 years
impulse control disorder
as measured by questionnaire visual files: clinical evaluation by ophthalmologist and perimetry
Time frame: up till 2 years
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