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Trial registered on ANZCTR


Registration number
ACTRN12620000581965
Ethics application status
Approved
Date submitted
6/04/2020
Date registered
19/05/2020
Date last updated
19/05/2020
Date data sharing statement initially provided
19/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Temazepam or Melatonin Versus Placebo for the Treatment of INsomnia in Advanced CAncer: A Three Arm, Double Blind, Phase III, Multicentre, Randomised Clinical Trial
Scientific title
Temazepam or Melatonin Versus Placebo for the Treatment of INsomnia in Advanced CAncer: A Three Arm, Double Blind, Phase III, Multicentre, Randomised Clinical Trial
Secondary ID [1] 301124 0
Nil known
Universal Trial Number (UTN)
Trial acronym
INCA
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Insomnia in advance cancer 316903 0
Condition category
Condition code
Cancer 315080 315080 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Temazepam 10mg, Day 1 to day 7, once daily 1 oral capsule 30 minutes before bed
Arm B: Melatonin PR 2mg, Day 1 to day 7, once daily 1 oral capsule 30 minutes before bed
Arm C: Placebo, Day 1 to day 7, once daily 1 oral capsule 30 minutes before bed
Intervention code [1] 317242 0
Treatment: Drugs
Comparator / control treatment
Placebo is a microcrystalline cellulose powder
Control group
Placebo

Outcomes
Primary outcome [1] 323389 0
The effectiveness of temazepam and melatonin PR on patient reported sleep quality after 7 days using the Insomnia Severity Index (ISI). Each of the treatments will be compared to placebo
Timepoint [1] 323389 0
Day 8
Secondary outcome [1] 381780 0
The impact of temazepam and melatonin PR using EORTC QoL-C15-PAL.
Timepoint [1] 381780 0
Day 8
Secondary outcome [2] 381833 0
To study the tolerability of temazepam and melatonin PR. This is a composite secondary outcome including the following:
Delirium will be measured by the hospital admissions for delirium
Falls will be measured by self reported frequency of falls
Day time sleepiness will be measured by Karolinska Sleepiness Score
Timepoint [2] 381833 0
Day 8
Secondary outcome [3] 381834 0
The effect of temazepam and melatonin PR on patient reported sleep quality as measured using Modified Pittsburgh Sleep Quality Index (mPSQI).
Timepoint [3] 381834 0
Day 8
Secondary outcome [4] 381835 0
The impact of temazepam and melatonin PR on Patients’ Global Impression of Change will be measured using Global Impression of Change.
Timepoint [4] 381835 0
Day 8

Eligibility
Key inclusion criteria
Patient has provided written informed consent
Male or female patients aged equal or above 18 years
Presence of advanced cancer of any aetiology
Patient has an Insomnia Severity Score (ISI) above 11
Australian modified Karnofsky performance status equal or above 40%.
Patient is willing and able to comply with the protocol requirements for the duration of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient has pain or other unstable symptoms that the clinician and patient feels is directly contributing to poor sleep unless the symptom is optimally treated with no potential to change during the course of the study Patients with unstable symptoms can be re-screened once the symptoms are stable
Patient who has taken any prescription medication for sleep within 3 days prior to randomisation.
Patients on prescription medication for sleep can be re-screened once medication has been ceased for 3 or more days
Concurrent use of benzodiazepines for any indication
Patient has had more than 2 falls in the past week
Patients on varying doses of corticosteroids for any reason during the intervention period or 3 days prior to randomisation
Plan for surgery during the study period
Formally diagnosed active and uncontrolled alcohol or substance abuse disorder Intolerance to melatonin or temazepam
Patient is pregnant or lactating
Unstable psychiatric illness as assessed by the clinician
Any contraindication listed on the product description for temazepam or melatonin
The patient is on another clinical trial of an investigational agent that is likely to interfere with sleep

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed according to the intention to treat principle which will include all patients who were randomised in the treatment arm they were randomised to.
Baseline characteristics will be summarised by mean and standard deviations (SDs) for continuous variables, and counts and percentages for categorical variables.
The primary objective will be assessed by comparing the ISI score at Day 8 in each of the active arms, temazepam and melatonin PR, independently to the placebo arm using a student t-test. The mean ISI score in each treatment arm will be calculated and given (along with its standard error), as well as the mean difference between each of the active arms and placebo with a 95% confidence interval.
The same statistical method will be used to compare temazepam and melatonin PR to placebo on quality of life, daytime sleepiness and global impression of change at day 8.
If either of the treatment arms was shown to be superior to placebo, then the two active arms will be compared using the same methods to determine whether any of the active treatment arms was superior to the other. If neither active arm was superior to placebo, the two active arms will not be compared.
The same statistical method will be used to compare the two treatments, temazepam and melatonin, to each other in terms of all of the primary and secondary objectives :
Insomnia measured by using the Insomnia Severity Index (ISI).
Qol using EORTC QoL-C15-PAL.
Delirium will be measured by the hospital admissions for delirium
Falls will be measured by self reported frequency of falls
Day time sleepiness will be measured by Karolinska Sleepiness Score
Patient reported sleep quality as measured using Modified Pittsburgh Sleep Quality Index (mPSQI)
Patient Global Impression of Change (PGIC)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
1/06/2022
Actual
Date of last data collection
Anticipated
15/06/2022
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16367 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 16368 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 16370 0
Western Hospital - Footscray - Footscray
Recruitment hospital [4] 16371 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 16372 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 29911 0
3050 - Parkville
Recruitment postcode(s) [2] 29912 0
3000 - Melbourne
Recruitment postcode(s) [3] 29914 0
3011 - Footscray
Recruitment postcode(s) [4] 29915 0
3084 - Heidelberg
Recruitment postcode(s) [5] 29916 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 305373 0
Hospital
Name [1] 305373 0
Western Health
Country [1] 305373 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
176 Furlong Rd, St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 305750 0
Other Collaborative groups
Name [1] 305750 0
The Victorian Comprehensive Cancer Centre
Address [1] 305750 0
Level 10/305 Grattan St, Melbourne VIC 3000
Country [1] 305750 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305703 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 305703 0
Ethics committee country [1] 305703 0
Australia
Date submitted for ethics approval [1] 305703 0
21/01/2020
Approval date [1] 305703 0
30/03/2020
Ethics approval number [1] 305703 0
HREC/61226/MH-2020

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101290 0
Dr Ruwani Mendis
Address 101290 0
Western Health
Department of Palliative Care
Sunshine Hospital
176 Furlong Road
St Albans VIC 3021
Country 101290 0
Australia
Phone 101290 0
+61 3 8345 1333
Fax 101290 0
Email 101290 0
[email protected]
Contact person for public queries
Name 101291 0
Ruwani Mendis
Address 101291 0
Western Health
Department of Palliative Care
Sunshine Hospital
176 Furlong Road
St Albans VIC 3021
Country 101291 0
Australia
Phone 101291 0
+61 3 8345 1333
Fax 101291 0
Email 101291 0
[email protected]
Contact person for scientific queries
Name 101292 0
Ruwani Mendis
Address 101292 0
Western Health
Department of Palliative Care
Sunshine Hospital
176 Furlong Road
St Albans VIC 3021
Country 101292 0
Australia
Phone 101292 0
+61 3 8345 1333
Fax 101292 0
Email 101292 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
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.
How or where can data be obtained?
Data can be obtain by emailing the sponsor Western Health [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.