None listed
Conditions
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.
Interventions
ARM A. Sertraline 50mg tablets. One tablet once a day by mouth.
Sponsors
CTC
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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.
Exclusion criteria
No exclusion criteria
Outcome results
None listed