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Trial registered on ANZCTR


Registration number
ACTRN12612000650897
Ethics application status
Approved
Date submitted
18/06/2012
Date registered
19/06/2012
Date last updated
24/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of corticosteroids versus placebo on sleep quality in patients with advanced cancer
Scientific title
A double-blind, placebo-controlled cross-over study of the effect of corticosteroids on sleep quality- a pilot study in patients with advanced cancer
Secondary ID [1] 280199 0
None
Universal Trial Number (UTN)
UTN U1111-1129-1929
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced cancer 286135 0
Sleep disturbance 286731 0
Condition category
Condition code
Cancer 286328 286328 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284527 0
Treatment: Drugs
Comparator / control treatment
Both arms in this cross-over trial will act as control as well as intervention arms. Both arms will receive both active and placebo treatments each day; it is the order in which these are received (morning vs evening) that will be manipulated. The placebo will be an inert substance encapsulated to match dexamethasone capsules, delivered once a day in either the morning or evening.
Control group
Placebo

Outcomes
Primary outcome [1] 287343 0
Sleep quality, as assessed by the sleep disturbance sub scale of the Verran and Snyder-Halpern (VSH) sleep scale.
Timepoint [1] 287343 0
Baseline and daily for 10 days
Secondary outcome [1] 296675 0
Degree of sleep effectiveness (VSH sub scale)
Timepoint [1] 296675 0
Baseline and daily for 10 days
Secondary outcome [2] 296676 0
Sleep supplementation (VSH sub scale)
Timepoint [2] 296676 0
Baseline and daily for 10 days
Secondary outcome [3] 296677 0
Use of nocturnal sedation
Timepoint [3] 296677 0
Baseline and daily for 10 days
Secondary outcome [4] 296678 0
Use of breakthrough medication
Timepoint [4] 296678 0
Baseline and daily for 10 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pharmacy will be contacted whenever a patient is under-going the screening process to warn them of a potential trial candidate. This will be followed up by a confirmatory
call as soon as the patient's eligibility has been confirmed. The randomisation request will take the form of the prescription of the study drugs.

The site clinical trials pharmacist will prepare the study drugs for the participant according to the allocation determined by a published 2 arm randomisation schedule
ie whether to start with bottle A or B on the morning of day 1.

They will have previously labelled all dexamethasone capsules as A orB (and all placebo capsules as the other) but will blind the investigators to this allocation.

The allocation will be recorded on the schedule along with the date of allocation, the signature of the pharmacist preparing the drugs and the patient ID number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated using random permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 5151 0
4101
Recruitment postcode(s) [2] 5152 0
2065
Recruitment postcode(s) [3] 5153 0
2164
Recruitment postcode(s) [4] 5154 0
2217

Funding & Sponsors
Funding source category [1] 284945 0
Charities/Societies/Foundations
Name [1] 284945 0
JP Kelly Mater Research Foundation
Address [1] 284945 0
Mater Health Services Brisbane,
Raymond Terrace,
South Brisbane
QLD 4101
Country [1] 284945 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Health Services Brisbane Ltd
Address
Raymond Terrace,
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 283819 0
None
Name [1] 283819 0
Address [1] 283819 0
Country [1] 283819 0
Other collaborator category [1] 260648 0
Other Collaborative groups
Name [1] 260648 0
Improving Palliative Care through Clinical Trials (ImPaCCT)
Address [1] 260648 0
Faculty of Nursing, Midwifery & Health, Building 10, Level 7, UTS, 235-253 Jones St, Ultimo, NSW 2007
Country [1] 260648 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286957 0
Mater Health Services HREC
Ethics committee address [1] 286957 0
Raymond Terrace
South Brisbane
QLD 4101
Ethics committee country [1] 286957 0
Australia
Date submitted for ethics approval [1] 286957 0
Approval date [1] 286957 0
01/08/2008
Ethics approval number [1] 286957 0
1193A
Ethics committee name [2] 286958 0
Cancer Institute NSW
Ethics committee address [2] 286958 0
Cancer Institute NSW
Australian Technology Park
Level 9, 8 Central Avenue
Eveleigh, NSW 2015
Ethics committee country [2] 286958 0
Australia
Date submitted for ethics approval [2] 286958 0
Approval date [2] 286958 0
03/08/2011
Ethics approval number [2] 286958 0
2011C/06/163
Ethics committee name [3] 291118 0
St Vincent's Hospital Sydney
Ethics committee address [3] 291118 0
390 Victoria St, Darlinghurst NSW 2010
Ethics committee country [3] 291118 0
Australia
Date submitted for ethics approval [3] 291118 0
03/08/2013
Approval date [3] 291118 0
08/10/2013
Ethics approval number [3] 291118 0
HREC/13/SVH/241

Summary
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.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 33964 0
Prof Janet Hardy
Address 33964 0
Department of Palliative and Supportive Care, Mater Health Services, Division of Cancer Services, Level 10 Mater Adult Hospital, Raymond Terrace, South Brisbane, QLD 4101
Country 33964 0
Australia
Phone 33964 0
+61 7 3163 3884
Fax 33964 0
+61 7 3163 8856
Email 33964 0
janet.hardy@mater.org.au
Contact person for public queries
Name 17211 0
Ms Angela Tapuni
Address 17211 0
Department of Palliative and Supportive Care, Mater Health Services, Division of Cancer Services, Level 10 Mater Adult Hospital, Raymond Terrace, South Brisbane, QLD 4101
Country 17211 0
Australia
Phone 17211 0
+61 7 3163 3884
Fax 17211 0
+61 7 3163 8856
Email 17211 0
Angela.Tapuni@mater.org.au
Contact person for scientific queries
Name 8139 0
Ms Angela Tapuni
Address 8139 0
Department of Palliative and Supportive Care, Mater Health Services, Division of Cancer Services, Level 10 Mater Adult Hospital, Raymond Terrace, South Brisbane, QLD 4101
Country 8139 0
Australia
Phone 8139 0
+61 7 3163 3884
Fax 8139 0
+61 7 3163 8856
Email 8139 0
Angela.Tapuni@mater.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary