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Trial registered on ANZCTR


Registration number
ACTRN12609000794202
Ethics application status
Approved
Date submitted
1/07/2008
Date registered
14/09/2009
Date last updated
6/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Using single patient trials to determine the effectiveness of psychostimulants in fatigue in advanced cancer patients
Scientific title
Using Single Patient Trials to determine the effectiveness of psychostimulants in fatigue in advanced cancer patients
Secondary ID [1] 646 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fatigue 3350 0
palliative care 3351 0
Condition category
Condition code
Other 3505 3505 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Cancer 3506 3506 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Methylphendiate -In single patient trials each patient undergoes 3 pairs of treatment periods. Each treatment period is 3 days (thus each pair is 6 days). The order of Methylphenidate and placebo will be determined by random allocation, blinded to both clinician and patient. The dose will be 5mg bi-daily (oral capsules). The drug will be capsules administered bi-daily by the patient. The drug and placebo will be packaged for patients ease of use. Methylphenidate has a short half life, so there is no wash out period between pairs. The data from the first of each 3 day period will be removed from analysis in case of any carry over effect of the drug. The intervention will be a total of 18 days.
Intervention code [1] 3086 0
Treatment: Drugs
Comparator / control treatment
Placebo - capsule with non active ingredients
Control group
Placebo

Outcomes
Primary outcome [1] 4409 0
Fatigue - measured by the 'Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) & Wu Cancer Fatigue scales. The FACIT F is reliable and valid and a 3 point change represents a clinically important improvement in fatigue
Timepoint [1] 4409 0
Daily after intervention has commenced until day 18
Secondary outcome [1] 7439 0
Depression - measured using the Edinburgh Depression Scale
Timepoint [1] 7439 0
Every 3 days (end of 3 days of each cycle)
Secondary outcome [2] 7440 0
Global Impression of Change is a 7 point likert scale measuring overall improvement
Timepoint [2] 7440 0
Every 3 days (end of 3 days of each cycle)

Eligibility
Key inclusion criteria
1. Patients with advanced cancer
2. = 18 years of age.
3. Australia-modifed Karnofsky Performance Status (AKPS) score of ?40.
4. Fatigue score ? 4/10 on screening for fatigue using a single screening questionnaire adopted from the National Comprehensive Cancer Network (NCCN) cancer-related fatigue guidelines. (7)
5. Treatment regimen (including steroids) stable for at least 48 hours and likely to remain stable throughout the trial period.
6. No treatment likely to influence fatigue during the course of the clinical trial (examples will be presented in operational procedures)
7. No change in thyroxine therapy or antidepressant therapy for the 3 weeks prior to study.
8. Ability to understand and conform to all study requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to comprehend written English.
2. Confusion or Mini-Mental State Examination < 24
3. Unstable symptoms or disease such that the patient is unlikely to be able to complete all study requirement over the 2 week study period
4. History of severe ischaemic heart disease
5. Uncontrolled cardiac arrhythmias or hypertension
6. Electrolyte imbalances (Na, K, Mg, Ca) where attempt at correction would be appropriate.
7. Anemia for which a blood transfusion is indicated as a treatment for fatigue
8. Erythropoietin therapy in the 2 weeks prior to study.

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)
In a single patient trial the patient acts as their own control. Patients are randomly allocated to receive methylphenidate or placebo first for 3 days within a 6 day pair (Pair 1). Random allocation of treatment occurs for Pair 2 and Pair 3 as well. Allocation is centrally randomised by computer, pharmacy, and cheif invesitgator are aware of allocation, however trating physician and patient are unaware.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Single patient trial. Patient acts as own control.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2009
Actual
22/10/2009
Date of last participant enrolment
Anticipated
20/12/2011
Actual
29/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 2405 0
Gold Coast Hospital - Southport
Recruitment hospital [2] 2406 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 2407 0
Braeside Hospital - Prairiewood
Recruitment hospital [4] 2408 0
Ipswich Hospital - Ipswich
Recruitment hospital [5] 2409 0
St Vincent's Hospital Brisbane - Kangaroo Point
Recruitment postcode(s) [1] 1014 0
4006
Recruitment postcode(s) [2] 1015 0
4101

Funding & Sponsors
Funding source category [1] 3544 0
Government body
Name [1] 3544 0
National Health and Medical Research Council
Country [1] 3544 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
University of Queensland,
Sir Fred Schonell Dr
St Lucia, Queensland, 4072
Country
Australia
Secondary sponsor category [1] 3182 0
None
Name [1] 3182 0
Address [1] 3182 0
Country [1] 3182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5685 0
Medical Research Ethics Committee
Ethics committee address [1] 5685 0
University of Queensland,
Queensland 4072
Ethics committee country [1] 5685 0
Australia
Date submitted for ethics approval [1] 5685 0
Approval date [1] 5685 0
14/12/2007
Ethics approval number [1] 5685 0
2007001571
Ethics committee name [2] 239322 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [2] 239322 0
Raymond Terrace
South Brisbane
Queensland 4101
Ethics committee country [2] 239322 0
Date submitted for ethics approval [2] 239322 0
Approval date [2] 239322 0
28/05/2009
Ethics approval number [2] 239322 0
1330A

Summary
Brief summary
Objectives: A) To determine a population estimate of the efficacy of Mehtylphenidate in alleviating fatigue in patients with advanced cancer. B) To provide process evaluation on the feasibility of Single Patient Trials as a routine means of conducting clinical trials in palliative care. C) To develop, employ and recommend appropriate statistical techniques for the analysis of Single Patient Trial data derived from patients with advanced cancer; specifically, to develop and evaluate a method that estimates the effect of patient deterioration over the conduct of clinical trials and, where appropriate, provides a means of adjusting for illness progression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28717 0
Prof Geoff Mitchell
Address 28717 0
The University of Queensland
12 Salisbury Rd
Ipswich 4305
Country 28717 0
Australia
Phone 28717 0
61 7 3381 1363
Fax 28717 0
Email 28717 0
[email protected]
Contact person for public queries
Name 11874 0
Sue-Ann Carmont
Address 11874 0
Discipline of General Practice,
School of Medicine
Lvl 2, Edith Cavell Bldg,
Royal Brisbane Hospital
Herston, Qld 4006
Country 11874 0
Australia
Phone 11874 0
+ 61 7 3365 5014
Fax 11874 0
Email 11874 0
[email protected]
Contact person for scientific queries
Name 2802 0
Sue-Ann Carmont
Address 2802 0
Discipline of General Practice,
School of Medicine
Lvl 2, Edith Cavell Bldg,
Royal Brisbane Hospital
Herston, Qld 4006
Country 2802 0
Australia
Phone 2802 0
+ 61 7 3365 5014
Fax 2802 0
Email 2802 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseThe effect of methylphenidate on fatigue in advanced cancer: An aggregated N-of-1 trial.2015https://dx.doi.org/10.1016/j.jpainsymman.2015.03.009
N.B. These documents automatically identified may not have been verified by the study sponsor.