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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients submitted to adjuvant chemotherapy with 5-FU isolated
Patients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
São Paulo, Brazil
cardiac function evaluation
Cardiac function will be assessed by two-dimensional (B-mode) echocardiography, pulsed Doppler
Time frame: Change from Baseline cardiac function at 6 months
vascular function evaluation
Vascular function will be assessed by high resolution Doppler ultrasound
Time frame: Change from Baseline vascular function at 6 months
autonomic control evaluation
autonomic control will be assessed by microneurography and heart rate variability
Time frame: Change from autonomic control at 6 months
functional capacity evaluation
functional capacity will be assessed by cardiopulmonary exercise test
Time frame: Change from Baseline functional capacity at 6 months
Proinflammatory cytokines
Proinflammatory cytokines will be assessed by blood evaluations
Time frame: Change from Baseline Proinflammatory cytokines at 6 months
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