Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): A Phase II Pilot Study to Improve Quality of Life During Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 43
- 主要终点
- Change in the MHI-17 global psychological distress subscale
研究概览
简要总结
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.
详细描述
OBJECTIVES:
Primary Objectives:
- 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.
- 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:
- To describe the tumor response rate associated with the administration of gemcitabine/cisplatin in patients with advanced non-small cell lung cancer.
- To describe the overall survival and failure-free survival associated with the administration of gemcitabine/cisplatin.
- To describe the toxicity associated with the administration of gemcitabine/cisplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
gemcitabine + cisplatin + fluoxetine
Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician.
干预措施: cisplatin (Drug)
gemcitabine + cisplatin + fluoxetine
Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician.
干预措施: fluoxetine (Drug)
gemcitabine + cisplatin + fluoxetine
Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Change in the MHI-17 global psychological distress subscale
时间窗: Up to 8 weeks
Overall survival
时间窗: Up to 2 years post-treatment
Failure-free survival
时间窗: Up to 2 years post-treatment
次要结局
未报告次要终点