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Trial registered on ANZCTR


Registration number
ACTRN12608000405314
Ethics application status
Approved
Date submitted
30/07/2008
Date registered
19/08/2008
Date last updated
19/05/2023
Date data sharing statement initially provided
19/05/2023
Date results provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised, double blind control trial of megestrol acetate, dexamethasone and placebo in the management of anorexia in people with cancer
Scientific title
Randomised, double blind control trial of megestrol acetate, dexamethasone and placebo in the management of anorexia in people with cancer
Secondary ID [1] 251762 0
005/07
Universal Trial Number (UTN)
Trial acronym
Megestrol, dexamethasone and placebo for anorexia.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia 3482 0
Condition category
Condition code
Cancer 3638 3638 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double blind, placebo controlled, randomized Phase III trial of
3 arms: megestrol acetate 480 mg/day vs. Dexamethasone 4 mg/day vs. placebo for up to 4 weeks according to weekly response assessment for appetite.
Intervention code [1] 3206 0
Treatment: Drugs
Comparator / control treatment
Capsules containing cornstarch, manufactured to look identical to the interventions
Control group
Placebo

Outcomes
Primary outcome [1] 4536 0
Change in appetite score on a Numeric Rating Scale for appetite at 1 week, with response defined as 25% increase in the baseline score.
Timepoint [1] 4536 0
At baseline and at one week after intervention commencement
Secondary outcome [1] 7723 0
To compare the effect of megestrol acetate and dexamethasone on quality of life (measured by the European organization for Research and Treatment of Cancer- Quality of Life Questionnaire- core questions and the Functional assessment of appetite in cancer therapy).
Timepoint [1] 7723 0
1 week after treatment commencement
Secondary outcome [2] 7724 0
To compare the effect of megestrol acetate and dexamethasone on functional status (measured by the Australian Modified Karnofsky Performance Status, and the Eastern Co-operative Oncology Group scales).
Timepoint [2] 7724 0
1 week after treatment commencement
Secondary outcome [3] 7680 0
To compare the short and intermediate adverse effect profiles of megestrol acetate and dexamethasone using the National Institutes of Health Common Terminology Criteria for Adverse Event Assessment V3.0.
Timepoint [3] 7680 0
4 weeks after treatment commencement
Secondary outcome [4] 7678 0
To compare the effect of megestrol acetate and dexamethasone on: patient weight and rate of weight change (measured by Body Mass Index).
Timepoint [4] 7678 0
1 week after treatment commencement
Secondary outcome [5] 7679 0
To compare the overall duration of administration of these medications
Timepoint [5] 7679 0
4 weeks after treatment commencement
Secondary outcome [6] 7681 0
To compare the relative costs of treatment of dexamethasone and megestrol acetate
Timepoint [6] 7681 0
4 weeks after treatment commencement

Eligibility
Key inclusion criteria
Age: 18 years and above
Able to speak English (or have an interpreter available) to complete all assessments
Mentally competent: Able to understand the information given and to provide informed consent
Able to reliably take oral medication and has an intact gastrointestinal tract.
Diagnosis of cancer.
Clinical prediction of survival: > 6 weeks
Functional performance status: ECOG (Eastern Co-operative Oncology Group) 0-3 or AKPS (Australian Modified Karnofsky Performance Status) 40-100
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of thromboembolic disease without adequate anti-coagulation, Concurrent corticosteroids or progestogens. Previous adverse reaction to megestrol acetate or dexamethasone Concurrent androgens, cannabinoids, olanzepine or other psychostimulants (antidepressants or anti-psychotics) being used primarily for appetite stimulation. Tube feedings or parenteral nutrition Clinically significant evidence of ascites (i.e. shifting dullness on physical examination) or pleural effusions Poorly controlled congestive heart failure: ejection fraction (<20%, measured in past 6 months) or NYHA (New York Heart Foundation) class IV Severe hypertension Patients with vascular access devices (e.g Portacaths) who are not having prophylactic anticoagulation Diabetes controlled by diet and/or oral medication Pregnant or nursing Active systemic infection at the start of treatment Diarrhoea as defined by 5 or more watery stools per day for at least 7 days.

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)
Over the course of the study, participants will be allocated a series of identifying numbers. A two digit study number, a two digit site number, and a sequential three digit screening number will be allocated on referral to the study. This ID number will be used for all subsequent study documentation for that participant. In addition, a 4 digit randomisation number will be allocated on randomisation of the participant. The full number sequence will be unique to that participant and will not be reassigned.

At all times, from eligibility screening to completion of the study, all study staff are unaware of the treatment allocation. Allocation is concealed from the investigator at the time of the participant inclusion in the trial. The central registry will supply the schedule tables to the dispensing pharmacy for allocation.

The dispensing pharmacist will allocate sequential codes according to the supplied schedule and identify the active or inactive study medications delivered in a pre-filled blister pack. The blister pack number, dates of preparation and dispensing will be recorded in a log maintained by the pharmacist.

All capsules will be prepared in a central manufacturing pharmacy, where the tablets will be encased in an opaque capsule in order to have all study drugs and the placebo looking identical. Each capsule will then be filled with cornstarch to prevent rattling of contents. Each daily dose for each participant will be sealed into a blister pack within a strip containing a 1 week supply of the study medication.

Each blister pack will be numbered according to the pre-determined allocation code and labeled as;

Study 005/07 megestrol study. megestrol acetate 480mg, dexamethasone 4mg, placebo. Take 3 capsules every morning until finished.

All blister packs for each site will be supplied to the site clinical trial pharmacist according to the randomisation schedule with a log of the blister pack number. On randomisation of a participant, the site pharmacist will obtain the blister pack corresponding to the randomisation number, and record the participant details in a log against the blister pack number. Allocation concealment is via the use of numbered packs containing the prepared capsules. Randomisation is conducted by an independent pharmacist who does not have contact with the study participants.

Treatment allocation will not be disclosed to participant, study staff, treating clinicians or investigators. The code will only be broken in cases of extreme emergency. Such situations only include where knowledge of the code will have consequences for clinical decision making.

On randomisation at each site, the site pharmacist will locate the next lowest numbered blister pack. The pack will have a pharmacy label attached which will state the patient name and details, and the ID number. A log will be maintained of the pack number dispensed to each participant.

The intervention will be delivered as opaque capsules. At each dose, the individually labeled blister pack will be opened and the daily dose will be removed for administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedules will be developed for each site using random number tables, generated at an independent centre (central registry). Treatment for each patient will be allocated according to a block randomisation schedule held by the central registry in a 1:1:1 ratio. Block randomisation will ensure even allocation to each code in each site. This is described in more detail within the PaCCSC Randomisation Standard Operating Procedure. The central registry will supply the schedule tables to the dispensing pharmacy for allocation.
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
None
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
21/01/2009
Date of last participant enrolment
Anticipated
Actual
31/03/2015
Date of last data collection
Anticipated
Actual
5/05/2015
Sample size
Target
159
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7508 0
3065 - Fitzroy
Recruitment postcode(s) [2] 9789 0
4101 - South Brisbane
Recruitment postcode(s) [3] 7504 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 7509 0
5041 - Daw Park
Recruitment postcode(s) [5] 7505 0
2298 - Waratah
Recruitment postcode(s) [6] 7506 0
2164 - Wetherill Park
Recruitment postcode(s) [7] 7503 0
2065 - Greenwich
Recruitment postcode(s) [8] 7507 0
3215 - Geelong North

Funding & Sponsors
Funding source category [1] 3659 0
Government body
Name [1] 3659 0
Commonwealth Department of Health and Ageing
Country [1] 3659 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders Drive, Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 3287 0
Government body
Name [1] 3287 0
Commonwealth Department of Health and Ageing
Address [1] 3287 0
GPO Box 9848 Canberra, ACT, 2601
Country [1] 3287 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258971 0
Ballarat Health Services & St John of God Health Care Ethics Committee
Ethics committee address [1] 258971 0
Ethics committee country [1] 258971 0
Australia
Date submitted for ethics approval [1] 258971 0
21/01/2009
Approval date [1] 258971 0
25/03/2009
Ethics approval number [1] 258971 0
EC00207
Ethics committee name [2] 258976 0
Sydney South West Area Health Service (SSWAHS) Royal Prince Alfred Hospital Ethics Review Committee (RPAH Zone)
Ethics committee address [2] 258976 0
Ethics committee country [2] 258976 0
Australia
Date submitted for ethics approval [2] 258976 0
26/08/2008
Approval date [2] 258976 0
09/02/2009
Ethics approval number [2] 258976 0
EC00113
Ethics committee name [3] 258972 0
Barwon Health Research Ethics Committee
Ethics committee address [3] 258972 0
Ethics committee country [3] 258972 0
Australia
Date submitted for ethics approval [3] 258972 0
15/03/2010
Approval date [3] 258972 0
03/06/2010
Ethics approval number [3] 258972 0
EC00208
Ethics committee name [4] 292988 0
Mater Health Services HREC
Ethics committee address [4] 292988 0
Ethics committee country [4] 292988 0
Australia
Date submitted for ethics approval [4] 292988 0
12/08/2008
Approval date [4] 292988 0
03/10/2008
Ethics approval number [4] 292988 0
EC00332
Ethics committee name [5] 5713 0
Southern Adelaide Health Service / Flinders University Human Research Ethics Committee
Ethics committee address [5] 5713 0
Ethics committee country [5] 5713 0
Australia
Date submitted for ethics approval [5] 5713 0
14/08/2008
Approval date [5] 5713 0
10/02/2009
Ethics approval number [5] 5713 0
EC00188
Ethics committee name [6] 258974 0
St John of God Health Care Ethics Committee
Ethics committee address [6] 258974 0
Ethics committee country [6] 258974 0
Australia
Date submitted for ethics approval [6] 258974 0
06/08/2009
Approval date [6] 258974 0
08/04/2010
Ethics approval number [6] 258974 0
EC00286
Ethics committee name [7] 258970 0
Alfred Hospital Ethics Committee
Ethics committee address [7] 258970 0
Ethics committee country [7] 258970 0
Australia
Date submitted for ethics approval [7] 258970 0
22/05/2009
Approval date [7] 258970 0
04/12/2009
Ethics approval number [7] 258970 0
EC00315
Ethics committee name [8] 258977 0
St Vincent's Hospital (Melbourne) HREC D
Ethics committee address [8] 258977 0
Ethics committee country [8] 258977 0
Australia
Date submitted for ethics approval [8] 258977 0
12/05/2009
Approval date [8] 258977 0
24/09/2009
Ethics approval number [8] 258977 0
EC00343
Ethics committee name [9] 258975 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [9] 258975 0
Ethics committee country [9] 258975 0
Australia
Date submitted for ethics approval [9] 258975 0
21/08/2008
Approval date [9] 258975 0
08/01/2009
Ethics approval number [9] 258975 0
EC00235
Ethics committee name [10] 258973 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [10] 258973 0
Ethics committee country [10] 258973 0
Australia
Date submitted for ethics approval [10] 258973 0
31/10/2008
Approval date [10] 258973 0
04/02/2009
Ethics approval number [10] 258973 0
EC00266

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

Contacts
Principal investigator
Name 28790 0
Prof David Currow
Address 28790 0
Deputy Vice-Chancellor (Research & Sustainable Futures), University of Wollongong NSW 2522 Australia
Country 28790 0
Australia
Phone 28790 0
+61 2 4221 5354
Fax 28790 0
+61 8 8374 0350
Email 28790 0
david.currow@uow.edu.au
Contact person for public queries
Name 11947 0
David Currow
Address 11947 0
Deputy Vice-Chancellor (Research & Sustainable Futures), University of Wollongong NSW 2522 Australia
Country 11947 0
Australia
Phone 11947 0
+61 2 4221 5354
Fax 11947 0
+61 8 8374 0350
Email 11947 0
david.currow@uow.edu.au
Contact person for scientific queries
Name 2875 0
David Currow
Address 2875 0
Deputy Vice-Chancellor (Research & Sustainable Futures), University of Wollongong NSW 2522 Australia
Country 2875 0
Australia
Phone 2875 0
+61 2 4221 5354
Fax 2875 0
+61 8 8374 0350
Email 2875 0
david.currow@uow.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data related to demographics and baseline medical conditions, data related to primary and secondary outcomes
When will data be available (start and end dates)?
From 1st June 2023 to 1st June 2030
Available to whom?
Other researchers with research question approved by the study investigator team
Available for what types of analyses?
Those analyses described in approved proposals only
How or where can data be obtained?
Available from the Lead Investigator via email 9david.currow@uow.edu.au0


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.