NCT01806259已完成3 期
Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Recurrence-free Survival
研究概览
简要总结
Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio >4 and/or "triple negative" histological status and/or Positive lymph nodes
排除标准
- •Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )
研究组 & 干预措施
ketorolac 30 mg
Experimental
Active drug to be compared with placebo
干预措施: Ketorolac 30 mg IV (Drug)
NaCl 0.9% 3mL
Placebo Comparator
Placebo looking like the Active drug
干预措施: Placebos (Drug)
结局指标
主要结局
Recurrence-free Survival
时间窗: 5 years
2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
次要结局
未报告次要终点
研究者
Patrice Forget
Docteur
Université Catholique de Louvain
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Ketorolac during breast cancer surgeryBreast cancerEUCTR2012-003774-76-BECUS203
已完成
1 期
Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid UseBreast ReductionBreast ReconstructionNCT04439396Carilion Clinic183
招募中
4 期
The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction SurgeryHematoma PostoperativeNCT03535116Dr. Chandran Medical Prof Corp100
尚未招募
不适用
Effect of Ketorolac of VEGF and TGF-B release in breast cancer resection surgery.CTRI/2021/06/034467All India Institute of Medical Sciences
已完成
2 期
Treatment of postoperative pain with intravenous ketorolac in mandibular fracture surgeryAcute pain.Acute painIRCT201607271674N13Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences50