An interventional study of adjuvant chemotherapy with 5-FU isolated and adjuvant chemotherapy with 5-FU associated with oxaliplatin in Colon Cancer and Adjuvant Chemotherapy, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 30 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
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Exclusion Criteria:
adjuvant chemotherapy with 5-FU isolated
Drug: adjuvant chemotherapy with 5-FU isolated
adjuvant chemotherapy with 5-FU associated with oxaliplatin
Drug: adjuvant chemotherapy with 5-FU associated with oxaliplatin
Patients submitted to adjuvant chemotherapy with 5-FU isolated
Patients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin
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
Plan to share: No
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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital