TerminatedPhase 3ACTRN12605000381684

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

A double-blind, placebo-controlled trial of Zoloft's Effects on Symptoms and survival Time in Advanced Cancer


Sponsor

CTC

Enrollment

440 participants

Start Date

May 1, 2002

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and females

Inclusion Criteria1

  • 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.

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Interventions

ARM A. Sertraline 50mg tablets. One tablet once a day by mouth.

ARM A. Sertraline 50mg tablets. One tablet once a day by mouth.


Locations(1)

Australia

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ACTRN12605000381684