Depression Clinical Trial
Official title:
Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): A Phase II Pilot Study to Improve Quality of Life During Chemotherapy
This trial is designed to test the efficacy of fluoxetine to improve patient's quality of life during chemotherapy. An innovative application of a selective serotonin reuptake inhibitor may modulate the effects of fatigue, anxiety and depression which worsen quality of life.
OBJECTIVES:
Primary Objectives:
1. To preliminarily test the efficacy of fluoxetine to improve the quality of life of
patients with advanced non-small cell lung cancer receiving chemotherapy by decreasing
anxiety, depression and fatigue.
2. To test the feasibility of conducting a multi-center clinical trial of fluoxetine
administered by oncologists concurrently with chemotherapy in patients with non-small
cell lung cancer.
Secondary Objectives:
1. To describe the tumor response rate associated with the administration of
gemcitabine/cisplatin in patients with advanced non-small cell lung cancer.
2. To describe the overall survival and failure-free survival associated with the
administration of gemcitabine/cisplatin.
3. To describe the toxicity associated with the administration of gemcitabine/cisplatin.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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