Randomized Phase II Clinical Trial of Oral Turmeric Supplementation in Patients With Advanced Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Compare overall survival and progression free survival
研究概览
简要总结
Determine the efficacy and safety of turmeric in the treatment of patients with advanced cervical cancer. Efficacy will be determined through radiological and histopathological criteria through the rate of response to treatment, duration of response, the rate of objective response and disease control, as well as overall survival and disease-free survival. The safety of therapy will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) classification
详细描述
A placebo-controlled phase II clinical trial will be developed in patients with advanced cervical cancer who have an indication for radiotherapy. Those who accept to participate will receive the standard treatment with established chemo-radiation and will be randomized in two arms, the experimental will receive 500mg of the commercial presentation (curcugreen) c / 6h VO x 16 weeks and the control arm will receive placebo. The operative hypotheses are: the addition of curcumin to the treatment improves the cumulative probability of 3-year overall survival by 20% and improves the treatment response rate. The statistical analysis will include a Cox proportional hazards model and the results of the groups will be compared with the Student's T-test or ANOVA. This research hopes to collect tissue samples for future research that allows the identification of predictive biomarkers and disease prognoses.
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
- Double (Participant, Investigator)
盲法说明
double blind masking
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years or older
- •Voluntary acceptance of participation and signing of informed consent
- •Radiotherapy indication
- •Histological confirmation of squamous cervical cancer or histologically confirmed adenocarcinoma
- •Stage IIB - VAT
- •Chemo-radiation indication with Cisplatin, Cisplatin/fluorouracil, Carboplatin (if cisplatin intolerant)
- •ECOG equal to or less than 1 and a Karnofsky index equal to or greater than 70%.
排除标准
- •Being pregnant or breastfeeding
- •Presence of second concomitant neoplasia
- •Any previous surgical, radiotherapy or chemotherapy treatment.
- •Diagnosis of invasive recurrent carcinoma of the cervix
- •Receive anticoagulant therapy
- •Receive immunosuppression therapy
- •Presence of coagulation disorders, such as platelet count less than 100,000 at the time of the joint evaluation, absolute neutrophil count less than 1,500 / ml
- •Presence of signs of systemic infection
- •Renal failure, creatinine clearance less than 45 ml/min confirmed with glomerular filtration less than 45 ml / min; evidence of unilateral renal exclusion
- •Patients with uncontrolled metabolic disease
研究组 & 干预措施
Curcumin
Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Curcugreen (BCM95) 2000mg daily (each 6h)
干预措施: Curcumin (Drug)
Placebo
Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Placebo Capsules 500mg 2000mg daily (each 6h)
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Compare overall survival and progression free survival
时间窗: 3 yr
Global survival
Compare the objective response rate using RECIST radiological criteria
时间窗: 1 yr
Objective response by RECIST criteria
Compare the disease control rate
时间窗: 1 yr
Disease control rate
次要结局
- Describe the safety of research therapy by classifying Common Terminology Criteria for Adverse Events (CTCAE)(1 yr)