Plain English Summary
Not provided at time of registration
Study website
http://www.ctc.usyd.edu.au/trials/cancer/other_cancer_trials.htm
Contact information
Type
Scientific
Contact name
Dr Martin Stockler
ORCID ID
Contact details
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown
New South Wales
1450
Australia
+61 (0)2 9562 5000
stockler@med.usyd.edu.au
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
Version 1.0, dated October 2004 - ACTRN012605000381684
Study information
Scientific title
Acronym
The ZEST Trial
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Advanced Cancer
Intervention
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.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Sertraline (Zoloft®)
Primary outcome measure
1. Quality of life (depression, anxiety and fatigue)
2. Survival
3. Adverse events
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/05/2002
Overall study end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type(s)
Patient
Age group
Not Specified
Sex
Both
Target number of participants
450
Participant exclusion criteria
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)
Recruitment start date
01/05/2002
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Australia
Study participating centre
NHMRC Clinical Trials Centre
Camperdown, New South Wales
1450
Australia
Sponsor information
Organisation
National Health and Medical Research Council (NHMRC) Clinical Trials Centre (Australia)
Sponsor details
Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown
New South Wales
1450
Australia
+61 (0)2 9562 5362
ccarter@ctc.usyd.edu.au
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
New South Wales Cancer Council (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer - supplied study drug (sertraline and placebo) free of charge
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2007 | Yes | No |