CTRI/2025/09/094572尚未招募不适用
Impact of Metformin on Hematologic and Metabolic Profiles in Patients with Breast Cancer and Type 2 Diabetes Mellitus: Real-World Evidence from a Retrospective Matched Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Mean change in Hemoglobin
研究概览
简要总结
The study is a Retrospective Cohort Study based on real world evidence which assesses the impact of Metformin on Hematologic and Metabolic Profiles in Patients with Breast Cancer and Type 2 Diabetes Mellitus which assess the possible hemoprotective, hepatoprotective and renoprotective effects of metformin in patients who are on chemotherapy and antidiabetic medication which involves a broader area of polypharmacy
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients aged above 18 years Histologically confirmed diagnosis of Breast Cancer Diagnosed with T2DM and receiving anti-diabetic medication Patient received chemotherapy between 01 Jan 2022 and 31 Dec 2024.
排除标准
- •Patients with any other concurrent or prior invasive malignancy.
- •Patients in whom metformin was stopped (for any reason) and shifted to other antidiabetic agents within 1 month prior to chemotherapy initiation.
结局指标
主要结局
Mean change in Hemoglobin
时间窗: Baseline and 3 months and 6 months
次要结局
- Other Hematologic Outcomes(Mean change in RBC counts WBC counts Platelet counts MCV MCH MCHC at)
- Renal Outcome(a. Mean change in serum creatinine and creatinine clearance at three and six months)
- Hepatic Outcome(a. Mean change in alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total proteins, albumins, globulin and serum bilirubin levels at three and six months)
- Exploratory Outcome Measures(a. Hospitalizations related to metabolic or hematologic complications any time during adjuvant or neoadjuvant chemotherapy)
研究者
Vaishnavi Yanamandra
Kasturba Medical College, Manipal
研究点 (1)
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