EUCTR2015-004172-30-DE进行中（未招募）1 期
Prevention of paclitaxel-related neurological side effects with lithium – a randomized, double-blind, placebo-controlled, explorative proof-of-concept phase II clinical trial to counteract chemotherapy induced neurotoxicity
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Written informed consent is present
- •- The patient has the capacity to give consent (she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention.)
- •- Age 18-70 years
- •- Recent diagnosis of breast cancer to be treated with weekly or biweekly paclitaxel therapy
- •- Karnofsky index =70 %
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •- The patient is pregnant or breastfeeding
- •- The patient with childbearing potential is not willing to use an acceptable form of contraception.
- •- The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons.
- •- The patient did or does participate in other interventional trials (6 months before and at the time of this trial)
- •- The patient is legally detained in an official institution
- •- The patient is an employee of the investigator study site, or a family member of the employees or the investigator, or otherwise dependent on the sponsor, the investigator or study physicians.
- •- The patient previously received neurotoxic chemotherapy (especially: taxanes, platinum compounds, vinca alcaloids, proteasome inhibitors)
- •- The patient has a history of preexisting neuropathy with a baseline TNSr > 5
- •- The patient has a history of current or former alcohol or drug abuse or Carbohydrate Deficient Transferrin (CDT) > 2.4 % or urine drug screening is positive
- •- The patient has a cardiac pacemaker or other non-MRI suitable implants
- •Lithium carbonate:
- •- The patient has a known allergy against Lithium carbonate or other components of the IMP
- •- The patient has hereditary galactose intolerance, lactose insufficiency or glucose-galactose-malabsorption
- •- The patient has Brugada-Syndrom or Myasthenia gravis
- •- The patient’s family history is positive for lethal sudden cardiac arrest
- •- The patient uses phenytoin, fosphenytoin, carbamazepine, methyldopa, tricyclic antidepressants
- •- The patient has a diagnosis of severe cardiac arrhythmia
- •- The patient has a diagnosis of epilepsy, M. Addison, psoriasis
- •- The patient has chronic renal disease with a GFR <70ml/min/1.73m2
- •- Allergy to cellulose or lactose
- •Paclitaxel:
- •- The patient has a known allergy against paclitaxel or other components of the standard-medication
- •- The patient has a diagnosis of severe liver failure
研究者
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