Condition category
Cancer
Date applied
22/12/2004
Date assigned
31/03/2005
Last edited
10/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctc.usyd.edu.au/trials/cancer/other_cancer_trials.htm

Contact information

Type

Scientific

Primary contact

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 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

Not provided at time of registration

Study design

Double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Phase III

Drug names

Sertraline (Zoloft®)

Primary outcome measures

1. Quality of life (depression, anxiety and fatigue)
2. Survival
3. Adverse events

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2002

Overall trial end date

31/12/2006

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17548243

Publication citations

  1. Results

    Stockler MR, O'Connell R, Nowak AK, Goldstein D, Turner J, Wilcken NR, Wyld D, Abdi EA, Glasgow A, Beale PJ, Jefford M, Dhillon H, Heritier S, Carter C, Hickie IB, Simes RJ, , Effect of sertraline on symptoms and survival in patients with advanced cancer, but without major depression: a placebo-controlled double-blind randomised trial., Lancet Oncol., 2007, 8, 7, 603-612, doi: 10.1016/S1470-2045(07)70148-1.

Additional files

Editorial Notes