ISRCTN32332192已完成未知
Primary Prevention of Anthracycline-induced Cardiotoxicity with L-Carnitine in patients with breast Cancer (PPACC): pilot study
niversity of Ottawa Heart Institute (Institut de cardiologie de l'Université d'Ottawa) (Canada)0 个研究点目标入组 144 人开始时间: 2007年4月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Breast cancer patients (stages I, II, III) eligible for adjuvant epirubicin chemotherapy (5-Fluorouracil, Epirubicin, and Cyclophosphamide [FEC]-100)
- •2. Eastern Cooperative Oncology Group (ECOG) performance status equals zero to two
- •3. Informed consent
- •Amended as of 20/04/2007:
- •1. Women, aged greater than or equal to 18 years
- •2. Breast cancer patients (stages I, II, III) eligible for adjuvant epirubicin chemotherapy (FEC100)
- •3. HER2 negative breast cancer by immunohistochemistry (IHC3+) and/or fluorescent in-situ hybridization
- •4. Eastern Cooperative Oncology Group (ECOG) performance status equal to zero to two
- •5. Ability to understand and the willingness to sign a written informed consent document
- •6. Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
排除标准
- •1. Resting LVEF less than 50%
- •2. Previous anthracycline therapy or contraindication to anthracycline
- •3. Contraindication to L-carnitine therapy
- •4. Dexrazoxane therapy at the time of enrolment
- •5. Participation in another randomised clinical trial
- •6. Significant cardiac disease (previous myocardial infarction, congestive heart failure, haemodynamically significant valvular heart disease)
- •7. Medication that may affect LV function or symptoms of heart failure (beta-blockers, amiodarone, Angiotensin Converting Enzyme [ACE]-inhibitors, calcium channel blockers, digoxin)
- •8. Aged less than 18 years or inability to give informed consent
- •9. Evidence of metastatic breast cancer
- •10. Patients unable to participate in a study requiring long term follow up
- •11. Abnormal baseline: Complete blood count (Haemoglobin [Hb] less than 100 mg/L, Platelets [Plt] less than 100 x 10^9/L, White Blood Cells [WBC] less than 4 x 10^9/L), creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) or bilirubin greater than 1.5 times the upper limit of normal
- •Amended as of 20/04/2007:
- •1. Resting LVEF less than 50%
- •2. Previous anthracycline therapy or contraindication to anthracycline
- •3. Contraindication to L-carnitine therapy
- •4. Dexrazoxane therapy at the time of enrollment
- •5. Participation in another randomised clinical trial
- •6. Significant cardiac disease (previous myocardial infarction, congestive heart failure, hemodynamically significant valvular heart disease)
- •7. Medication that may affect LV function or symptoms of heart failure (b-blockers, amiodarone, ACE-inhibitors, calcium channel blockers, digoxin)
- •8. Pregnant or lactating women
- •9. Evidence of metastatic breast cancer.
- •10. Patients unable to participate in a study requiring long term follow up
- •11. Abnormal baseline: Complete blood count (Hb less than 100 mg/L, Plt less than 100 x 10^9/L, WBC less than 4 x 10^9/L), Creatinine AST, ALT or Bilirubin greater than or equal to 1.5 the upper limit of normal
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