NCT03847623Unknown不适用
Effect of Preoperative Curcumin in Breast Cancer Patients
适应症
干预措施
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
研究组 & 干预措施
Placebo
Placebo Comparator
Capsules, taken orally, bi-daily dosing
干预措施: Placebo (Other)
Curcumin
Experimental
Capsules, taken orally, 8g per day (Bi-daily dosing)
干预措施: Curcumin (Dietary Supplement)
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)
Loading locations...
相似试验
已完成
2 期
Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial CarcinomaEndometrial CarcinomaNCT02017353University Hospital, Gasthuisberg7
尚未招募
2 期
Evaluation of Curcumin's effect on inflammation in hemodialysis patients.End Stage Renal Disease.End stage renal diseaseN18.6IRCT20200613047751N1Tabriz University of Medical Sciences42
Unknown
2 期
A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer EarlyBreast CancerNCT00957125Thomas Hatschek151
招募中
2 期
The effect of curcumin on septic patientssepsis.Sepsis with septicemiaA41.9IRCT20211023052849N2Tehran University of Medical Sciences60
已完成
1 期
Effect of Curcumin on Dose Limiting Toxicity and Pharmacokinetics of Irinotecan in Patients With Solid TumorsAdvanced Colorectal CancerNCT01859858UNC Lineberger Comprehensive Cancer Center23