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临床试验/NCT03213444
NCT03213444已完成不适用

Impact of Adjuvant Chemotherapy in Cardiovascular Autonomic Regulation in Patients With Colon Cancer

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
cardiac function evaluation

研究概览

简要总结

The present study aims to investigate the impact of adjuvant chemotherapy with 5-FU isolated and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent vascular function in patients undergoing colectomy for stages II and III colon cancer. Will be performed evaluation of cardiac and vascular function, autonomic control, functional capacity and blood evaluations.

详细描述

Cancer is a major public health problem. Colorectal cancer is the third most common cancer in men and women around the world. Despite advances in surgical and pharmacological treatment, this type of cancer remains a leading cause of cancer death in Western countries. The adjuvant chemotherapy treatment based on the use of fluoropyrimidine, especially 5-fluorouracil (5-FU) is the mainstay of the pharmacological treatment of colorectal cancer. This treatment showed benefit in overall survival and progression-free survival in the adjuvant treatment of patients with stage II and III disease. In the last decade, the combination treatment with oxaliplatin has shown benefit in patients with either metastatic disease as with locoregional disease who underwent surgical treatment. However, the increased use of 5-FU and oxaliplatin, and increased patient survival have caused increased incidence of adverse events. 5-FU has cardiotoxic effects that may range from 1.2 to 18% depending upon the drug administration. Another adverse event of chemotherapy for colon cancer is neurotoxicity. Peripheral neuropathy is one of the toxicities associated with treatment with Oxaliplatin and its characteristics to be dose-dependent and cumulative. Thus, the adjuvant chemotherapy with 5-FU and oxaliplatin may cause cardiotoxicity, changes in vascular function and increased oxidative stress. What is not known are the effects of treatment of 5-FU and oxaliplatin in cardiac autonomic modulation and peripheral vascular function. Therefore, the present study aims to investigate the impact of adjuvant chemotherapy with 5-FU isolated and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent vascular function in patients undergoing colectomy for stages II and III colon cancer. Will be performed evaluation of cardiac and vascular function, autonomic control, functional capacity and blood evaluations.

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
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scale of Performance Status 0 - 1
  • Patients submitted to colectomy for adenocarcinoma of colon stages II and III.

排除标准

  • Severe pulmonary disease
  • Decompensated cardiovascular disease
  • Neurological disease
  • Insulin-dependent diabetes mellitus
  • Dialysis renal insufficiency

研究组 & 干预措施

Quimioterapy 1

Active Comparator

adjuvant chemotherapy with 5-FU isolated

干预措施: adjuvant chemotherapy with 5-FU isolated (Drug)

Quimioterapy 2

Active Comparator

adjuvant chemotherapy with 5-FU associated with oxaliplatin

干预措施: adjuvant chemotherapy with 5-FU associated with oxaliplatin (Drug)

结局指标

主要结局

cardiac function evaluation

时间窗: Change from Baseline cardiac function at 6 months

Cardiac function will be assessed by two-dimensional (B-mode) echocardiography, pulsed Doppler

次要结局

  • vascular function evaluation(Change from Baseline vascular function at 6 months)
  • autonomic control evaluation(Change from autonomic control at 6 months)
  • functional capacity evaluation(Change from Baseline functional capacity at 6 months)
  • Proinflammatory cytokines(Change from Baseline Proinflammatory cytokines at 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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