The effect of corticosteroids versus placebo on sleep quality in patients with advanced cancer

Phase 2

Completed

• Conditions: Advanced cancer; Sleep disturbance; Cancer - Any cancer

• Registration Number: ACTRN12612000650897
• Lead Sponsor: Mater Misericordiae Health Services Brisbane Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

a diagnosis of cancer
-on a stable dose of corticosteroid (CS) for the previous 48hours for any indication
-likely to remain on a stable dose of CS for the next 10 days
-patients on another CS other than dexamethasone must be prepared to convert to an equivalent dose of dexamethasone
- likely to remain on a stable doses of sedatives, hypnotics and analgesics throughout study period.
- likely to remain at home or in hospital (ie in a stable environment) for the duration of the study period
- life expectancy> 1 month
- able to swallow tablets
- ability to understand the patient information sheet, sign a fully informed consent and comply with trial requirements

Exclusion Criteria

-patients prescribed dexamethasone for emergency management, eg. spinal cord compression, superior vena cava syndrome, raised intracranial pressure (ICP)
-patients being weaned off steroids not willing to remain on a stable dose for 1 0 days
-a history of psychosis
-concurrent medication likely to cause insomnia eg psychostimulants
-uncontrolled diabetes mellitus

Study & Design

• Study Type: Interventional
• Study Design: Not specified