NCT03847623Unknown不适用
Effect of Preoperative Curcumin in Breast Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tumour infiltrating lymphocytes (TILs)
研究概览
简要总结
Effect of curcumin on modulation of immune and inflammatory parameters in pre-operative patients
详细描述
Patients diagnosed with breast cancer will be supplemented with either curcumin or placebo for a minimum period of 2 weeks and may be extended up to 4 weeks prior to their surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with operable breast cancer
- •Life expectancy of at least 3 months
- •Adequate organ function
- •No allergy to curcumin
- •Provides consent to participate in trial and adhere to the study protocol
排除标准
- •Receiving concomitant radiotherapy, hormonal, immune therapy or other investigational drugs
- •Uncontrolled concurrent illness
- •Patient of anti platelet medications
- •Pregnant / breast feeding
- •Patients who are unable or unwilling to take curcumin, herbal remedies, or non-prescription medications
- •Patients with bleeding tendency, bleeding disorders and abnormal bleeding/clotting profile
结局指标
主要结局
Tumour infiltrating lymphocytes (TILs)
时间窗: For 2 to 4 weeks
Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group
次要结局
- FOXP3(For 2 to 4 weeks)
- CD68(For 2 to 4 weeks)
研究者
Nur Aishah Mohd Taib
Professor
University of Malaya
研究点 (1)
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