Trial from ANZCTR


Trial ID ACTRN12609000794202
Trial Status: Registered
Date Submitted: 1/07/2008
Date Registered: 14/09/2009
Retrospectively registered

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Public title Using single patient trials to determine the effectiveness of psychostimulants in fatigue in advanced cancer patients
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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
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Secondary ID [1] 646 0
NIL
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
fatigue 3350 0
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palliative care 3351 0
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Condition category: Condition code:
Other Research that is not of generic health relevance and not applicable to specific health categories listed above
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3505 3505 0 0
Cancer Other cancer types
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3506 3506 0 0

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Descriptions 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.
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Intervention Code:
Treatment: drugs 3086 0
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Comparator / control treatment Placebo - capsule with non active ingredients
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Control group Placebo
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Primary Outcome: 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 4409 0
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Timepoint: Daily after intervention has commenced until day 18 4409 0
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Secondary Outcome: Depression - measured using the Edinburgh Depression Scale 7439 0
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Timepoint: Every 3 days (end of 3 days of each cycle) 7439 0
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Secondary Outcome: Global Impression of Change is a 7 point likert scale measuring overall improvement 7440 0
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Timepoint: Every 3 days (end of 3 days of each cycle) 7440 0
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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
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Crossover
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Other design features Single patient trial. Patient acts as own control.
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 2
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Anticipated date of first participant enrolment 14/07/2009
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 40
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Recruitment status Not yet recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: 4006 1014 0
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Postcode: 4101 1015 0
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Recruitment outside Australia

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Funding Source: Government body 3544 0
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Name: National Health and Medical Research Council 3544 0
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Address: Level 5, 20 Allara Street
Canberra ACT 2601
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Country: Australia 3544 0
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Primary Sponsor University
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Name: University of Queensland
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Address: University of Queensland,
Sir Fred Schonell Dr
St Lucia, Queensland, 4072
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Country: Australia
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Secondary Sponsor: None 3182 0
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Name: 3182 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Medical Research Ethics Committee 5685 0
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Address: University of Queensland,
Queensland 4072
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Country: Australia 5685 0
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Approval Date: 14/12/2007 5685 0
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Submitted Date: 5685 0
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HREC: 2007001571 5685 0
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Ethics Committee name: Mater Health Services Human Research Ethics Committee 239322 0
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Address: Raymond Terrace
South Brisbane
Queensland 4101
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Country: 239322 0
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Approval Date: 28/05/2009 239322 0
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Submitted Date: 239322 0
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HREC: 1330A 239322 0
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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.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Sue-Ann Carmont
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Address: Discipline of General Practice, School of Medicine Lvl 2, Edith Cavell Bldg, Royal Brisbane Hospital Herston, Qld 4006
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Country: Australia
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Tel: + 61 7 3365 5014
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Email: s.carmont@uq.edu.au
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Contact person for scientific queries
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Name: Sue-Ann Carmont
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Address: Discipline of General Practice, School of Medicine Lvl 2, Edith Cavell Bldg, Royal Brisbane Hospital Herston, Qld 4006
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Contact person responsible for updating information
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Name: Sue-Ann Carmont
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Address: Discipline of General Practice, School of Medicine Lvl 2, Edith Cavell Bldg, Royal Brisbane Hospital Herston, Qld 4006
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Country: Australia
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Addition Cancer fields
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