A feasibility study of lorazepam for anxiety in palliative care (LORAZEPAM Study)

Funding

Charities/Societies/Foundations,Peter MacCallum Cancer Centre Foundation

Scientific enquiries

Dr Nicola Atkin

Brief Summary

Anxiety is common in adults with advanced life-limiting disease, adversely affecting quality of life, social relationships and daily functioning at a critical time. This current study will assess the feasibility of a larger multi-centre, randomised, double-blind, placebo-controlled Phase III trial of oral lorazepam for symptoms of anxiety in participants with advanced life-limiting disease. Who is it for? You may be eligible to join this study if you are aged 18 and above with advanced life-limi .... Anxiety is common in adults with advanced life-limiting disease, adversely affecting quality of life, social relationships and daily functioning at a critical time. This current study will assess the feasibility of a larger multi-centre, randomised, double-blind, placebo-controlled Phase III trial of oral lorazepam for symptoms of anxiety in participants with advanced life-limiting disease. Who is it for? You may be eligible to join this study if you are aged 18 and above with advanced life-limiting disease receiving specialist palliative care input and experiencing symptoms of anxiety and meet all the inclusion and none of the exclusion criteria. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Arm 1 will be lorazepam and Arm 2 will be placebo. The study treatment will be commenced at a dose of 0.5mg (1 capsule) at night. If this is tolerated at Day 3, the dose will be increased to 0.5mg twice daily. A dose titration schedule with up to weekly dose review will then be followed. Each week the total daily dose may be increased by 0.5mg based on clinical assessment, adverse events assessment and HADS-A score, up to a maximum dose of 2mg twice daily (4 capsules twice daily). The study treatment will be continued for 12 weeks, unless criteria for discontinuation of treatment are met prior to this.
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Key Inclusion Criteria

Provide written informed consent. Age greater than or equal to 18 years. Inpatient or outpatient receiving specialist palliative care input. Advanced cancer (histological or clinical diagnosis) defined by intent of treatment no longer being curative or diagnosis of non-malignant advanced life-limiting illness. Persistent or recurrent anxiety causing clinically significant distress or functional impairment, as determined by the Investigator through clinical interview as part of the medical assess .... Provide written informed consent. Age greater than or equal to 18 years. Inpatient or outpatient receiving specialist palliative care input. Advanced cancer (histological or clinical diagnosis) defined by intent of treatment no longer being curative or diagnosis of non-malignant advanced life-limiting illness. Persistent or recurrent anxiety causing clinically significant distress or functional impairment, as determined by the Investigator through clinical interview as part of the medical assessment. Able to tolerate oral medication. Able to read and understand sufficient English to complete all required study questionnaires. Capable of completing assessments and complying with the study procedures.
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Key Exclusion Criteria

Psychiatric disorder other than anxiety or depression, unless stable for the past 3 months as assessed by the Investigator. Untreated depression, severe depression or suicidality as determined by the Investigator through clinical interview. Current or recent history of alcohol abuse or substance misuse. Formal diagnosis of severe respiratory failure (type 1 or 2). Formal diagnosis of sleep apnoea. Pregnant or breastfeeding. Uncontrolled physical symptoms, as determined by medical assessment. Hep .... Psychiatric disorder other than anxiety or depression, unless stable for the past 3 months as assessed by the Investigator. Untreated depression, severe depression or suicidality as determined by the Investigator through clinical interview. Current or recent history of alcohol abuse or substance misuse. Formal diagnosis of severe respiratory failure (type 1 or 2). Formal diagnosis of sleep apnoea. Pregnant or breastfeeding. Uncontrolled physical symptoms, as determined by medical assessment. Hepatic dysfunction as defined as serum alanine aminotransferase or bilirubin >3.5 x upper limit of normal. History of adverse reaction to benzodiazepine or the constituents in the placebo. Regular use of benzodiazepines (more than 2 doses within the past seven days). Antidepressant medication commenced or dose changed within the past month. Enrolment in another clinical trial with an investigational agent for anxiety or depression within 30 days of screening. Clinician predicted survival less than 14 days. Use of clozapine currently or within the past 4 weeks.
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