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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001338-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cabergoline | Experimental | 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 |
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| observation | No Intervention | visits and controls as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cabergoline | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| need for surgical and/or radiation treatment | up till 2 years | |
| changed pituitary function | measured by analysis of blood tests, basal and stimulation tests | up till 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven M Carlsen, prof md | Norwegian University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Akershus University hospital | Oslo | Norway | ||||
| Department of Endocrinology, St. Olavs Hospital |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| ID | Term |
|---|---|
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| change in tumour's distance to chiasma opticum in mm | as measured by analysis of MRI images | up till 2 years |
| development of cardiac valvulopathy | as measured by analysis of echo cardiography | up till 2 years |
| impulse control disorder | as measured by questionnaire visual files: clinical evaluation by ophthalmologist and perimetry | up till 2 years |
| Trondheim |
| 7006 |
| Norway |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |