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Trial registered on ANZCTR

Trial ID
Ethics application status
Date submitted
Date registered
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
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format
Using Single Patient Trials to determine the effectiveness of psychostimulants in fatigue in advanced cancer patients
Secondary ID 646 0
Universal Trial Number (UTN)
Trial acronym

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

Study type
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 3086 0
Treatment: drugs
Comparator / control treatment
Placebo - capsule with non active ingredients
Control group

Primary outcome 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 4409 0
Daily after intervention has commenced until day 18
Secondary outcome 7439 0
Depression - measured using the Edinburgh Depression Scale
Timepoint 7439 0
Every 3 days (end of 3 days of each cycle)
Secondary outcome 7440 0
Global Impression of Change is a 7 point likert scale measuring overall improvement
Timepoint 7440 0
Every 3 days (end of 3 days of each cycle)

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Single patient trial. Patient acts as own control.
Phase 2
Type of endpoint(s)

Anticipated date of first participant enrolment
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
Actual sample size
Recruitment status
Recruitment in Australia
Recruitment state(s)
Recruitment hospital 2405 0
Gold Coast Hospital - Southport
Recruitment hospital 2406 0
Calvary Mater Newcastle - Waratah
Recruitment hospital 2407 0
Braeside Hospital - Prairiewood
Recruitment hospital 2408 0
Ipswich Hospital - Ipswich
Recruitment hospital 2409 0
St Vincent's Hospital Brisbane - Kangaroo Point
Recruitment postcode(s) 1014 0
Recruitment postcode(s) 1015 0

Funding & Sponsors
Funding source category 3544 0
Government body
Name 3544 0
National Health and Medical Research Council
Address 3544 0
Level 5, 20 Allara Street
Canberra ACT 2601
Country 3544 0
Primary sponsor
Primary sponsor name
University of Queensland
Primary sponsor address
University of Queensland,
Sir Fred Schonell Dr
St Lucia, Queensland, 4072
Primary sponsor country
Secondary sponsor category 3182 0
Name 3182 0
Address 3182 0
Country 3182 0

Ethics approval
Ethics application status
Ethics committee name 5685 0
Medical Research Ethics Committee
Ethics committee address 5685 0
University of Queensland,
Queensland 4072
Ethics committee country 5685 0
Date submitted for ethics approval 5685 0
Approval date 5685 0
Ethics approval number 5685 0
Ethics committee name 239322 0
Mater Health Services Human Research Ethics Committee
Ethics committee address 239322 0
Raymond Terrace
South Brisbane
Queensland 4101
Ethics committee country 239322 0
Date submitted for ethics approval 239322 0
Approval date 239322 0
Ethics approval number 239322 0

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

Principal investigator
Name 28717 0
Prof Geoff Mitchell
Address 28717 0
The University of Queensland
12 Salisbury Rd
Ipswich 4305
Country 28717 0
Phone 28717 0
61 7 3381 1363
Fax 28717 0
Email 28717 0
Contact person for public queries
Name 11874 0
Ms 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
Phone 11874 0
+ 61 7 3365 5014
Fax 11874 0
Email 11874 0
Contact person for scientific queries
Name 2802 0
Ms 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
Phone 2802 0
+ 61 7 3365 5014
Fax 2802 0
Email 2802 0