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ISRCTN
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ISRCTN72466475
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ClinicalTrials.gov identifier
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Public title
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A double-blind, placebo-controlled trial of Zoloft's® Effects on Symptoms and survival Time in Advanced Cancer
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Scientific title
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Acronym
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The ZEST Trial
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Serial number at source
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Version 1.0, dated October 2004 - ACTRN012605000381684
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Double-blind placebo-controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Advanced Cancer
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Participants - inclusion criteria
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1. Advanced cancer defined by the presence of metastatic disease and treatment with palliative intent, that is to improve length and quality of life, but without realistic hope of cure
2. Symptomatic score greater than or equal to 4/10 for depression, anxiety, fatigue or lack of energy at baseline (assessment tool: Patient DATA form)
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Life expectancy of >3 months
5. Serum creatinine <200 µmol/l and bilirubin <30 µmol/l within 28 days of randomization
6. Able to complete baseline quality of life instruments
7. Availability and willingness for follow-up
8. Written informed consent
9. Women of childbearing potential must be taking adequate contraceptive precautions
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Participants - exclusion criteria
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1. Major depression, in other words, a clear indication for antidepressant treatment
2. Delirium i.e. impaired cognitive function (as detected by the Confusion Assessment Method, a screening tool for delirium assessing onset, course, inattention, disorganised thinking, level of consciousness)
3. History of hypersensitivity to sertraline
4. Diagnosis of carcinoid tumour
5. Coexisting conditions contraindicating treatment with serotonin reuptake inhibitors
6. Past history of schizophrenia or bipolar affective disorder
7. Treatment with antidepressants (including St John's Wort) or procarbazine within the last 4 weeks. Amitriptyline may be used at a daily dose of 25 mg or less as a co-analgesic or for urinary frequency, and is not an exclusion criterion.
8. Pregnant or lactating women. Women of childbearing potential are eligible if taking adequate contraceptive precautions.
9. Treatment with Tramadol in the last 7 days (ZEST participants should not use Tramadol because of the possibility of an interaction causing the serotonin syndrome)
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Anticipated start date
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01/05/2002
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Anticipated end date
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31/12/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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450
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Interventions
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Sertraline 50 mg, one tablet once daily by mouth with or without food or identical placebo, one tablet once daily by mouth with or without food.
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Primary outcome measure(s)
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1. Quality of life (depression, anxiety and fatigue)
2. Survival
3. Adverse events
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. New South Wales Cancer Council (Australia)
2. Pfizer - supplied study drug (sertraline and placebo) free of charge
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Trial website
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http://www.ctc.usyd.edu.au/trials/cancer/other_cancer_trials.htm
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Publications
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2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17548243
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Contact name
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Dr
Martin
Stockler
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Address
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NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
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City/town
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Camperdown, New South Wales
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Zip/Postcode
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1450
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Country
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Australia
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Tel
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+61 (0)2 9562 5000
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Fax
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+61 (0)2 9562 5094
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Email
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stockler@med.usyd.edu.au
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Sponsor
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National Health and Medical Research Council (NHMRC) Clinical Trials Centre (Australia)
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Address
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Clinical Trials Centre
University of Sydney
Locked Bag 77
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City/town
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Camperdown, New South Wales
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Zip/Postcode
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1450
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Country
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Australia
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Tel
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+61 (0)2 9562 5362
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Fax
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+61 (0)2 9562 5094
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Email
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ccarter@ctc.usyd.edu.au
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Date applied
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22/12/2004
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Last edited
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10/08/2009
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Date ISRCTN assigned
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31/03/2005
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