In short
Currently, there is 1 clinical trial investigating treatment options for benign pituitary tumours, specifically non-functioning pituitary adenomas. This trial is being conducted in Norway and is testing the effectiveness of cabergoline, a dopamine agonist medication, in reducing the size of these tumours.
Clinical trial locations
Study on Cabergoline for Treating Non-Functioning Pituitary Adenomas in Patients
This trial focuses on non-functioning pituitary adenomas, which are benign tumours located in the pituitary gland that do not produce excess hormones. Although these tumours are non-cancerous, they can grow in size and potentially press on nearby structures such as the optic nerves, which may lead to vision problems or affect normal pituitary gland function.
Main inclusion criteria: The study is open to adult patients, both male and female, who have been diagnosed with a non-functioning pituitary adenoma. To be eligible, participants must have a macroadenoma, meaning the tumour is 10 mm or larger at its largest point. The tumour must show evidence of growth on repeated MRI scans. If the tumour is near the chiasma opticum (a part of the brain near the eyes), it must be 2 mm or less away from this structure. Patients who have previously undergone surgery are also eligible if they have a remaining tumour of 5 mm or more in size that extends beyond the pituitary gland or shows growth after surgery.
Main exclusion criteria: Individuals who do not have a non-functioning pituitary adenoma cannot participate. Participants must fall within the specified age range for the study. Both males and females are eligible, but those who do not identify as either may not be able to participate. Additionally, people who belong to vulnerable populations, such as groups with limited ability to give informed consent or who are at higher risk of harm, may not be eligible.
Main focus and goal: The trial aims to evaluate how effective cabergoline is in treating non-functioning pituitary adenomas. Over a two-year study period, researchers will monitor participants using MRI scans to measure changes in tumour size, including any shrinkage or growth. The study will also assess whether additional treatments such as surgery or radiation become necessary. Throughout the trial, researchers will monitor changes in pituitary function, including the gland's ability to produce hormones, as well as any changes in vision or other nerve functions. The study will also examine the response of certain hormones, such as gonadotropins, and their relationship to tumour size.
Investigational drug: The medication being tested is cabergoline, which is taken orally in tablet form (Dostinex 0.5 mg). Cabergoline is a dopamine agonist, meaning it works by stimulating dopamine receptors in the brain. This action may help reduce the size of the adenomas and manage symptoms associated with these types of tumours. Participants will be randomly assigned to receive either cabergoline or a placebo, and the study will last for two years.
Summary
At present, there is one clinical trial available for patients with benign pituitary tumours, specifically targeting non-functioning pituitary adenomas. The trial is taking place in Norway and is investigating cabergoline as a potential treatment option. The study seeks to determine whether this dopamine agonist medication can effectively reduce tumour size and manage associated symptoms over a two-year period. Patients interested in participating should meet specific criteria related to tumour size, growth patterns, and previous treatment history. This research may provide valuable insights into alternative treatment approaches for individuals with these types of benign pituitary tumours who may be seeking options beyond surgery or radiation.
