The Effect of Metformin on Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical benefit rate (Tumor size)
研究概览
简要总结
Several clinical trials have addressed the promising anticancer effect of metformin on the survival benefits, clinical response, and pathological response of breast cancer patients.
Therefore, this study will assess the anticancer effect of metformin when added to the neoadjuvant chemotherapy protocol of non-diabetic breast cancer patients. In addition to, the impact of metformin addition to the neoadjuvant chemotherapy on the quality of life of breast cancer patients.
详细描述
This study is conducted to assess the effect of metformin addition to the chemotherapy protocol of non-diabetic breast cancer patients compared to the control group (non-metformin users) in the neoadjuvant setting. Evaluation of the the clinical benefit rate and the rate of pathological complete response will be conducted. In addition, a correlation between the beneficial effect of metformin and the serum concentration of metformin. Also, a comparison in the quality of life between the metformin group and the control group will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and (EORTC QLQ BR45) questionnaires will be done.
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment.
- •Female Age between 18- 65 years.
- •Written informed consent.
排除标准
- •Known hypersensitivity reaction to Metformin.
- •Intolerable Metformin GI complaints.
- •Patients at risk of lactic acidosis.
- •Diabetic breast cancer patients.
- •Body Mass Index < 18.5 (underweight breast cancer patients).
- •Renal impairment, eGFR <45 mL/min/1.73 m².
研究组 & 干预措施
metformin arm
4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery.
干预措施: Metformin (Drug)
metformin arm
4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel+ Metformin (1000 mg twice daily) followed by surgery.
干预措施: Chemotherapy (Drug)
control arm
4 cycles (Doxorubicin+Cyclophosphamide) followed by 12 cycles Paclitaxel followed by surgery.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Clinical benefit rate (Tumor size)
时间窗: 8 months
Tumor size measured in calipers from baseline till the last cycle of neoadjuvant chemotherapy.
次要结局
- Pathological complete response(8 months)
- Number of participants with metformin-related adverse events(8 months)
- The effect of metformin on the quality of life of breast cancer patients(8 months)
研究者
Hadeer Mohamed Ehab
Clinical Pharmacy Researcher
Beni-Suef University