The Impact of SGLT2i on the Outcome of Advanced Lung Cancer in Patients With Diabetes
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Number of Participants with death
概览
简要总结
The goal of this clinical trial
The goal of this clinical trial is to evaluate whether SGLT2 inhibitor drugs can extend overall survival or delay the progression of the tumor in patients with both advanced lung cancer and diabetes. It will also check if these drugs are safe for these patients. The main questions it aims to answer are:
- Does adding an SGLT2 inhibitor to standard cancer treatment improve survival?
- Does it cause more or fewer cardiovascular toxicity?
- What side effects do participants experience? Researchers will compare a group taking an SGLT2 inhibitor to a group not taking SGLT2 inhibitor to see if the drug works.
Participants will:
- Be adults diagnosed with advanced lung cancer and type 2 diabetes.
- Take either the SGLT2 inhibitor pill or other hypoglycemic drugs once a day alongside their cancer treatment.
- Undergo regular clinical visits for monitoring, laboratory tests, and imaging studies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Lung cancer patients receiving standard anti-tumor treatment; type 2 diabetes; patients with a score of 0-2 assessed by Eastern Cooperative Oncology Group's performance status; the patients agreed to participate in this study.
排除标准
- •Severe abnormalities in liver, kidney or heart functions; expected lifespan less than 3 months.
研究组 & 干预措施
treatment group
On the basis of standard cancer treatment, take dapagliflozin for at least three months, once a day, 10 mg each time.
干预措施: SGLT-2 inhibitor (Drug)
control group
Based on the standard treatment for tumors, for the treatment of diabetes, no dapagliflozin has been taken.
干预措施: Sham (No Treatment) (Other)
结局指标
主要结局
Number of Participants with death
时间窗: From enrollment to the end of treatment at 12 months
次要结局
- Number of Participants with new-onset atrial fibrillation/flutter, acute coronary syndrome, myocarditis, massive pericardial effusion, heart failure and third-degree atrioventricular block.(From enrollment to the end of treatment at 12 months)
研究者
Liang Zhao
Dr
Shanghai Chest Hospital