Assessment of the efficacy of Lanreotide Autogel® in the reversal of sleep apnoea, left ventricular hypertrophy and hypertension when used as primary medical therapy in acromegaly

Plain English summary of protocol

Background and study aims
Acromegaly is a relatively rare disorder, affecting 4-6 people per million per year. In the majority of cases, a swelling on the pituitary gland releases an excess of growth hormone (GH), which can cause the hands, feet, nose and jaw to enlarge and the skin to become greasy. The condition itself has often been present for some time before the diagnosis is made, and is frequently complicated by high blood pressure, diabetes, enlargement of the heart and sleep disturbance (typically manifesting as snoring). Left untreated, people with acromegaly have a higher risk of developing diseases such as angina, heart attacks and stroke, as well as suffering from problems directly related to the pituitary swelling (e.g. headaches and visual disturbance). Surgery by an experienced neurosurgeon remains the mainstay of treatment, although complete removal of the pituitary swelling is often not possible because of the risk of damage to important surrounding structures, including the nerves to the eyes. Accordingly, further treatment (either in the form of radiotherapy, drugs or, on occasion, both) is often required to control the condition. In recent years it has become standard clinical practice to consider medical treatment prior to surgery with a class of drug commonly referred to as somatostatin receptor ligands (SRLs). These drugs can lower GH levels and improve symptoms and in some instances this is associated with shrinkage of the pituitary swelling, which may improve the surgical outcome. Many centres now routinely offer ‘pre-treatment’ to newly diagnosed cases of acromegaly. However, it remains unclear as to how effective these drugs are in terms of correcting the sleep disturbance, high blood pressure, metabolic upset, blood vessel changes and heart enlargement of acromegaly. This study aims to examine the effectiveness of a drug called ‘Lanreotide Autogel’ in reversing blood pressure, cardiac and breathing pattern changes seen in many acromegaly patients before they proceed to surgery.

Who can participate?
Newly diagnosed patients with acromegaly, aged over 18, who have not undergone any previous medical or surgical treatment or radiotherapy for their acromegaly.

What does the study involve?
Participants are asked to score various symptoms of acromegaly (e.g. headache, sweating, fatigue, arthralgia, carpal tunnel syndrome) using a 5-point scale. A full physical examination is performed. Clinical assessments include height, weight, waist and hip circumference, blood pressure measurement, ring size and neck size. At the first visit, blood tests are carried out to confirm the diagnosis of acromegaly. Participants in whom the diagnosis is confirmed are then invited for a second visit during which a more detailed assessment is undertaken with hourly blood sampling to estimate average GH levels. Liver function, fasting glucose and lipid profiles are also checked. Detailed studies of the heart and blood vessels are performed using ultrasound and a magnetic resonance imaging (MRI) scan is performed to determine the pituitary tumour volume. Ultrasound scans of the liver and gallbladder are performed to look for evidence of gall stones and gallbladder polyps. The former can sometimes develop in patients receiving treatment with SRLs and so it is helpful for us to know if these are already present before treatment begins. Participants also undergo overnight sleep studies (polysomnography) to determine the severity of their sleep disturbance. All participants will receive an injection of short-acting SRL octreotide to gauge their likely response to a longer course of SRL treatment. Participants are then treated with the longer acting Lanreotide Autogel, with the dose determined based on their response to octreotide. At each visit, patients are asked to re-score their acromegaly symptoms. At the end of the study, participants are assessed again, as outlined above.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
University of Cambridge (UK).

When is study starting and how long is it expected to run for?
March 2004 to March 2014.

Who is funding the study?
IPSEN Fund, National Institute for Health Research, and Cambridge Biomedical Research Centre.

Who is the main contact?
Dr Mark Gurnell
mg299@medschl.cam.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Addenbrooke's NHS Trust R&D
Not defined

Cambridge University Hospitals NHS Foundation Trust
Box 277, Hills Road
Cambridge
CB2 0QQ
Cambridge
CB2 0QQ
United Kingdom

Email	sylvie.robinson@addenbrookes.nhs.uk
"ROR"	https://ror.org/055vbxf86

Funders

Funder type

Industry

Results and Publications

Study outputs

Editorial Notes

29/01/2018: Publication reference added.