NCT00247039Unknown1 期
A Controlled Study to Determine The Clinical Efficacy Of Garlic Compounds In Patients With Chemotherapy Related Febrile Neutropenia
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time to fever and beginning of empiric antibiotic treatment.
研究概览
简要总结
To determine the clinical effects of garlic in preventing and treatment of patients with chemotherapy related febrile neutropenia.These patients have a very high incidence of infections which are not routinely covered by the standard empiric therapy. Adding a non- toxic and possibly effective therapy may reduce the risk for infections, synergize the empiric antibiotic treatment and may lessen the need for broader spectrum and more severe side effects.
详细描述
Patients eligible are randomized to receive placebo or garlic capsules after chemotherapy course and until leukocyte recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FN patients expected to have at least 5 days or more of neutropenia will be eligible for treatment with garlic compounds AST/ALT ≤ 3 times the upper limit of institutional laboratory normal.
- •Total bilirubin ≤ 2 times the upper limit of institutional laboratory normal.
- •BUN and creatinine should be ≤ 3 times the upper limit of institutional laboratory normal.
- •Newly diagnosed as well as previously treated patients will be eligible.
排除标准
- •History of clinically significant liver or kidney disease.
- •Patients on anti-coagulation therapy with Coumadin will be excluded because of the potential garlic interference with metabolism.
- •Patients receiving concomitant chemotherapeutic treatment
结局指标
主要结局
Time to fever and beginning of empiric antibiotic treatment.
时间窗: 0-45 days post chemotherapy
次要结局
- Documented and culture positive infections.(as above)
- Kind of infectious organisms and sensitivity to medicines.(as above)
- Length of infection(as above)
- Use of growth factors.(as above)
研究者
Moshe Gatt
Dr. Moshe Gatt
Hadassah Medical Organization
研究点 (1)
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