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

The University of Melbourne

Dataset description

Demographic data for 15 adult patients with advanced cancer or advanced life-limiting disease and persistent or recurrent anxiety causing clinically significant distress or functional impairment at time of enrolment. 11 patients randomised to regular lorazepam treatment arm, 4 randomised to placebo, and treated for up to 12 weeks. Data collected at baseline, week 1,2,4,8,12 and follow-up at week 16 unless early discontinuation. Data includes anxiety measures (HADS-A, PROMIS 7a short form, PGIC), functional status (AKPS), other symptoms (ESAS), health-related quality of life (EQ 5D 5L), sleepiness (ESS), other adverse events and feasibility outcome data (recruitment, retention, completion of assessments, survival, acceptability, burden).
Click to explore relationships graph

Source Study




Phase 2


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 ....
Read more

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 ....
Read more

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 ....
Read more

Can healthy volunteers participate?




Sample Size    15

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Anxiety

Condition code    Mental Health


Intervention code Treatment: Drugs

The treatment with study drug - lorazepam will commence on Day 1, Week 1 and continue for up to 12 weeks. On Days 1 and 2 lorazepam will be taken as 1 capsule (0.5 mg) at night only. On Day 3 dose toxicity will be reviewed and if no toxicities occurred, the dose will be increased by 1 capsule (0.5 mg) and taken twice daily (in the morning and in the evening) starting from the following morning on Day 4. At the end of each week (1, 2, 3, 4 etc.) dose toxicity will be assessed and if no toxicities ....
Read more


Control group Placebo

Placebo as a size 3 gelatin capsule in opaque white containing maize starch.


Outcome: Feasibility - study will be considered feasible if at least 21 participants are enrolled within 12 months,etc
Timepoint: 12 months

Outcome: Feasibility- study will be considered feasible if at least 80% of enrolled participants completing 1 week of intervention and at least 80% of scheduled study assessments up to and including the End of Week 1 assessments
Timepoint: End of Week 1 assessments

Outcome: Participant retention on study and on study treatment at End of Week 1
Timepoint: End of Week 1

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

Applications to access data for secondary studies or other research purposes can be forwarded to the sponsor for consideration. All de-identified study data collected.

When will data be available?

From 3 months up to 3 years following main publication.

Available to whom?

This will be considered on case-by-case basis.

Available for what types of analyses?

Any purpose.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see