Impact of Adjuvant Chemotherapy in Patients With Colon Cancer
- Conditions
- Colon CancerAdjuvant Chemotherapy
- Interventions
- Drug: adjuvant chemotherapy with 5-FU isolated
- Registration Number
- NCT03213444
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Scale of Performance Status 0 - 1
- Patients submitted to colectomy for adenocarcinoma of colon stages II and III.
- Severe pulmonary disease
- Decompensated cardiovascular disease
- Neurological disease
- Insulin-dependent diabetes mellitus
- Dialysis renal insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quimioterapy 2 adjuvant chemotherapy with 5-FU associated with oxaliplatin adjuvant chemotherapy with 5-FU associated with oxaliplatin Quimioterapy 1 adjuvant chemotherapy with 5-FU isolated adjuvant chemotherapy with 5-FU isolated
- Primary Outcome Measures
Name Time Method cardiac function evaluation Change from Baseline cardiac function at 6 months Cardiac function will be assessed by two-dimensional (B-mode) echocardiography, pulsed Doppler
- Secondary Outcome Measures
Name Time Method vascular function evaluation Change from Baseline vascular function at 6 months Vascular function will be assessed by high resolution Doppler ultrasound
autonomic control evaluation Change from autonomic control at 6 months autonomic control will be assessed by microneurography and heart rate variability
functional capacity evaluation Change from Baseline functional capacity at 6 months functional capacity will be assessed by cardiopulmonary exercise test
Proinflammatory cytokines Change from Baseline Proinflammatory cytokines at 6 months Proinflammatory cytokines will be assessed by blood evaluations
Trial Locations
- Locations (1)
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
🇧🇷São Paulo, Brazil