Advanced Cancer Cancer Malignant neoplasm without specification of site
Conditions
Interventions
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.
Sponsors
National Health and Medical Research Council (NHMRC) Clinical Trials Centre (Australia)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Quality of life (depression, anxiety and fatigue) 2. Survival 3. Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Australia
Outcome results
None listed