A double-blind, placebo-controlled trial of Zoloft's® Effects on Symptoms and survival Time in Advanced Cancer
| ISRCTN | ISRCTN72466475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72466475 |
| Secondary identifying numbers | Version 1.0, dated October 2004 - ACTRN012605000381684 |
- Submission date
- 22/12/2004
- Registration date
- 31/03/2005
- Last edited
- 10/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Martin Stockler
Scientific
Scientific
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown, New South Wales
1450
Australia
| Phone | +61 (0)2 9562 5000 |
|---|---|
| stockler@med.usyd.edu.au |
Study information
| Study design | Double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | The ZEST Trial |
| Study hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 450 |
| 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 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
1450
Australia
Sponsor information
National Health and Medical Research Council (NHMRC) Clinical Trials Centre (Australia)
Research organisation
Research organisation
Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown, New South Wales
1450
Australia
| Phone | +61 (0)2 9562 5362 |
|---|---|
| ccarter@ctc.usyd.edu.au | |
"ROR" |
https://ror.org/011kf5r70 |
Funders
Funder type
Research organisation
New South Wales Cancer Council (Australia)
No information available
Pfizer - supplied study drug (sertraline and placebo) free of charge
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2007 | Yes | No |
