Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000381684
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
13/09/2005
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Date results information initially provided
29/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antidepressants, well-being and survival in advanced cancer. The ZEST Trial: A double-blind, placebo-controlled trial of Zoloft's Effects on Symptoms and survival Time in Advanced Cancer
Scientific title
A double-blind, placebo-controlled trial of Zoloft's Effects on Symptoms and survival Time in Advanced Cancer
Universal Trial Number (UTN)
Trial acronym
The ZEST Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with advanced cancer in whom there is doubt about the benefits of treatment with antidepressants. 485 0
Condition category
Condition code
Cancer 564 564 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM A. Sertraline 50mg tablets. One tablet once a day by mouth.
Intervention code [1] 418 0
Lifestyle
Comparator / control treatment
ARM B. Placebo. One sertraline placebo once a day. Patients will receive the study treatment indefinately, unless either the patient or doctor thinks there is a reason to stop.
Control group
Placebo

Outcomes
Primary outcome [1] 647 0
Health Related Quality of Life Measures
Timepoint [1] 647 0
At baseline, and then at 4, 8, 12, 16, 26, 39 and 52 weeks.
Secondary outcome [1] 1339 0
1. Overall survival
Timepoint [1] 1339 0
Outcomes are measured at Baseline, 4, 8, 12, 16, 26, 39, 52 weeks and then 3-monthly until death.
Secondary outcome [2] 1340 0
2. Safety and adverse events
Timepoint [2] 1340 0
Outcomes are measured at Baseline, 4, 8, 12, 16, 26, 39, 52 weeks and then 3-monthly until death.
Secondary outcome [3] 1341 0
3. Compliance, duration of therapy and reasons for discontinuation
Timepoint [3] 1341 0
Outcomes are measured at Baseline, 4, 8, 12, 16, 26, 39, 52 weeks and then 3-monthly until death.
Secondary outcome [4] 1342 0
4. Use of specific health resources.
Timepoint [4] 1342 0
Outcomes are measured at Baseline, 4, 8, 12, 16, 26, 39, 52 weeks and then 3-monthly until death.

Eligibility
Key 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 >= 4/10 for depression, anxiety, fatigue or lack of energy at baseline. 3.ECOG performance status 0-2. 4.Life expectancy of >3 months. 5.Serum creatinine <200 micromol/L and bilirubin <30micromol/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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
IVR system. Patients are stratified to balance for institution, gender, future cytotoxic treatment and performance status. Randomisation is based on minimisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Following a planned interim analysis, recruitment was put on hold while additional information was gathered and analysed. Recruitment did not resume. The final results of the trial included all 189 participants and longer follow-up.
Sertraline had little effect on depression, anxiety, fatigue or well-being. Irritability and sleeping were somewhat better with sertraline, but not a wide range of other common symptoms. Sertraline caused few side effects. Sertraline did not improve survival.
The ZEST Trial ruled out any major benefits of sertraline on symptoms, well-being, or survival in people with advanced cancer who did not have major depression.
Date of first participant enrolment
Anticipated
1/05/2002
Actual
1/05/2002
Date of last participant enrolment
Anticipated
Actual
16/03/2006
Date of last data collection
Anticipated
Actual
30/11/2006
Sample size
Target
440
Accrual to date
Final
189
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 613 0
Charities/Societies/Foundations
Name [1] 613 0
Cancer Council
Country [1] 613 0
Funding source category [2] 614 0
Commercial sector/Industry
Name [2] 614 0
Pfizer
Country [2] 614 0
Funding source category [3] 615 0
University
Name [3] 615 0
CTC
Country [3] 615 0
Australia
Primary sponsor type
University
Name
CTC
Address
Country
Australia
Secondary sponsor category [1] 500 0
University
Name [1] 500 0
CTC
Address [1] 500 0
Country [1] 500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1707 0
University of Sydney
Ethics committee address [1] 1707 0
Ethics committee country [1] 1707 0
Australia
Date submitted for ethics approval [1] 1707 0
Approval date [1] 1707 0
15/03/2002
Ethics approval number [1] 1707 0
Ethics committee name [2] 1708 0
The Canberra Hospital
Ethics committee address [2] 1708 0
Ethics committee country [2] 1708 0
Australia
Date submitted for ethics approval [2] 1708 0
Approval date [2] 1708 0
Ethics approval number [2] 1708 0
Ethics committee name [3] 1709 0
Royal Prince Alfred
Ethics committee address [3] 1709 0
Ethics committee country [3] 1709 0
Australia
Date submitted for ethics approval [3] 1709 0
Approval date [3] 1709 0
Ethics approval number [3] 1709 0
Ethics committee name [4] 1710 0
Prince of Wales
Ethics committee address [4] 1710 0
Ethics committee country [4] 1710 0
Australia
Date submitted for ethics approval [4] 1710 0
Approval date [4] 1710 0
Ethics approval number [4] 1710 0
Ethics committee name [5] 1711 0
Concord
Ethics committee address [5] 1711 0
Ethics committee country [5] 1711 0
Australia
Date submitted for ethics approval [5] 1711 0
Approval date [5] 1711 0
Ethics approval number [5] 1711 0
Ethics committee name [6] 1712 0
St. Vincent's Sydney
Ethics committee address [6] 1712 0
Ethics committee country [6] 1712 0
Australia
Date submitted for ethics approval [6] 1712 0
Approval date [6] 1712 0
Ethics approval number [6] 1712 0
Ethics committee name [7] 1713 0
Bathurst Base
Ethics committee address [7] 1713 0
Ethics committee country [7] 1713 0
Australia
Date submitted for ethics approval [7] 1713 0
Approval date [7] 1713 0
Ethics approval number [7] 1713 0
Ethics committee name [8] 1714 0
Wollongong
Ethics committee address [8] 1714 0
Ethics committee country [8] 1714 0
Australia
Date submitted for ethics approval [8] 1714 0
Approval date [8] 1714 0
Ethics approval number [8] 1714 0
Ethics committee name [9] 1715 0
Tamworth
Ethics committee address [9] 1715 0
Ethics committee country [9] 1715 0
Australia
Date submitted for ethics approval [9] 1715 0
Approval date [9] 1715 0
Ethics approval number [9] 1715 0
Ethics committee name [10] 1716 0
St. George
Ethics committee address [10] 1716 0
Ethics committee country [10] 1716 0
Australia
Date submitted for ethics approval [10] 1716 0
Approval date [10] 1716 0
Ethics approval number [10] 1716 0
Ethics committee name [11] 1717 0
Lismore Base
Ethics committee address [11] 1717 0
Ethics committee country [11] 1717 0
Australia
Date submitted for ethics approval [11] 1717 0
Approval date [11] 1717 0
Ethics approval number [11] 1717 0
Ethics committee name [12] 1718 0
Newcastle Mater
Ethics committee address [12] 1718 0
Ethics committee country [12] 1718 0
Australia
Date submitted for ethics approval [12] 1718 0
Approval date [12] 1718 0
Ethics approval number [12] 1718 0
Ethics committee name [13] 1719 0
Tweed Hospital
Ethics committee address [13] 1719 0
Ethics committee country [13] 1719 0
Australia
Date submitted for ethics approval [13] 1719 0
Approval date [13] 1719 0
Ethics approval number [13] 1719 0
Ethics committee name [14] 1720 0
Dubbo Base
Ethics committee address [14] 1720 0
Ethics committee country [14] 1720 0
Australia
Date submitted for ethics approval [14] 1720 0
Approval date [14] 1720 0
Ethics approval number [14] 1720 0
Ethics committee name [15] 1721 0
Nepean Cancer Care
Ethics committee address [15] 1721 0
Ethics committee country [15] 1721 0
Australia
Date submitted for ethics approval [15] 1721 0
Approval date [15] 1721 0
Ethics approval number [15] 1721 0
Ethics committee name [16] 1722 0
Orange Base
Ethics committee address [16] 1722 0
Ethics committee country [16] 1722 0
Australia
Date submitted for ethics approval [16] 1722 0
Approval date [16] 1722 0
Ethics approval number [16] 1722 0
Ethics committee name [17] 1723 0
Mater Hospital
Ethics committee address [17] 1723 0
Ethics committee country [17] 1723 0
Australia
Date submitted for ethics approval [17] 1723 0
Approval date [17] 1723 0
Ethics approval number [17] 1723 0
Ethics committee name [18] 1724 0
Calvary Hospital
Ethics committee address [18] 1724 0
Ethics committee country [18] 1724 0
Australia
Date submitted for ethics approval [18] 1724 0
Approval date [18] 1724 0
Ethics approval number [18] 1724 0
Ethics committee name [19] 1725 0
Riverina Cancer Care
Ethics committee address [19] 1725 0
Ethics committee country [19] 1725 0
Australia
Date submitted for ethics approval [19] 1725 0
Approval date [19] 1725 0
Ethics approval number [19] 1725 0
Ethics committee name [20] 1726 0
Peter MacCallum
Ethics committee address [20] 1726 0
Ethics committee country [20] 1726 0
Australia
Date submitted for ethics approval [20] 1726 0
Approval date [20] 1726 0
Ethics approval number [20] 1726 0
Ethics committee name [21] 1727 0
Royal Brisbane
Ethics committee address [21] 1727 0
Ethics committee country [21] 1727 0
Australia
Date submitted for ethics approval [21] 1727 0
Approval date [21] 1727 0
Ethics approval number [21] 1727 0
Ethics committee name [22] 1728 0
Townsville
Ethics committee address [22] 1728 0
Ethics committee country [22] 1728 0
Australia
Date submitted for ethics approval [22] 1728 0
Approval date [22] 1728 0
Ethics approval number [22] 1728 0
Ethics committee name [23] 1729 0
Nambour
Ethics committee address [23] 1729 0
Ethics committee country [23] 1729 0
Australia
Date submitted for ethics approval [23] 1729 0
Approval date [23] 1729 0
Ethics approval number [23] 1729 0
Ethics committee name [24] 1730 0
Royal Adelaide
Ethics committee address [24] 1730 0
Ethics committee country [24] 1730 0
Australia
Date submitted for ethics approval [24] 1730 0
Approval date [24] 1730 0
Ethics approval number [24] 1730 0
Ethics committee name [25] 1731 0
Flinders
Ethics committee address [25] 1731 0
Ethics committee country [25] 1731 0
Australia
Date submitted for ethics approval [25] 1731 0
Approval date [25] 1731 0
Ethics approval number [25] 1731 0
Ethics committee name [26] 1732 0
Sir Charles
Ethics committee address [26] 1732 0
Ethics committee country [26] 1732 0
Australia
Date submitted for ethics approval [26] 1732 0
Approval date [26] 1732 0
Ethics approval number [26] 1732 0

Summary
Brief summary
Symptoms of depression, anxiety, fatigue and lack of energy are common, important and closely related in people with advanced cancer. Modern antidepressants are highly effective at relieving these symptoms in people WITH clinical depression. This study will determine if a modern antidepressant can improve these symptoms in people with advanced cancer but WITHOUT clinical depression. Patients are randomized to receive either sertraline 50mg daily or placebo. Oncological, psychological, psychiatric, social and other support services are used according to standard best practice at that centre. Participants complete quality of life booklets and are reviewed at months 0, 1, 2, 3, 4, 6, 9, and 12.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35458 0
Address 35458 0
Country 35458 0
Phone 35458 0
Fax 35458 0
Email 35458 0
Contact person for public queries
Name 9607 0
Martin Stockler
Address 9607 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9607 0
Australia
Phone 9607 0
+61 2 95625313
Fax 9607 0
+61 2 95625094
Email 9607 0
stockler@med.usyd.edu.au
Contact person for scientific queries
Name 535 0
Martin Stockler
Address 535 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 535 0
Australia
Phone 535 0
+61 2 95625313
Fax 535 0
+61 2 95625094
Email 535 0
stockler@med.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.