None listed
Conditions
Brief summary
This is a study of the effects of a corticosteroid (dexamethasone) on sleep quality in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of cancer. You should be on a stable dose of corticosteroid for the previous 48 hours for any indication, and likely to remain on a stable dose of corticosteroids for the next 10 days. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take their usual dose of dexamethasone in the morning and a placebo (sham tablet) at night for five days, and then switch the order for the next five days (i.e. placebo in the morning and dexamethasone at night). Participants in the other group will complete this treatment in reverse order. Only the pharmacist will know which drugs are being taken when. Participants will be asked to complete a sleep questionnaire each morning in order to assess the effect of the timing of dexamethasone on sleep quality.
Interventions
This is a study of the effects of the timing (i.e. morning versus evening) of administration of dexamethasone on sleep quality. To be eligible, patients will need to already be on any dose of dexamethasone up to 8mg/day. This will delivered over 10 days as 2mg encapsulated tablets (or multiples of) in a daily dose in either the morning or evening as follows:
Treatment Group 1: Day 1-5: dexamethasone in the morning (0800-0900 hr) and matched dose placebo capsule in the evening (1700-1800hr); Day
This is a study of the effects of the timing (i.e. morning versus evening) of administration of dexamethasone on sleep quality. To be eligible, patients will need to already be on any dose of dexamethasone up to 8mg/day. This will delivered over 10 days as 2mg encapsulated tablets (or multiples of) in a daily dose in either the morning or evening as follows: Treatment Group 1: Day 1-5: dexamethasone in the morning (0800-0900 hr) and matched dose placebo capsule in the evening (1700-1800hr); Day 6-10: placebo in the morning and dexamethasone in the evening. Treatment Group 2: Day 1-5: placebo in the morning and dexamethasone in the evening; Day 6-10: dexamethasone in the morning and matched dose placebo capsule in the evening. There will be no 'wash-out' period between changes in the timing of dexamethasone on Days 5-6. The daily dose of dexamethasone will remain unchanged from the dose the patient was taking prior to participation.
Sponsors
Mater Misericordiae Health Services Brisbane Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed