Impact of Adjuvant Chemotherapy in Patients With Colon Cancer
Condition: Colon Cancer; Adjuvant Chemotherapy
MeSH terms: Colonic Neoplasms
Study type: Interventional

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.
    

Intervention name(s): adjuvant chemotherapy with 5-FU isolated; adjuvant chemotherapy with 5-FU associated with oxaliplatin
Intervention type(s): Drug; Drug
Intervention description(s): Patients submitted to adjuvant chemotherapy with 5-FU isolated; Patients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin
Intervention MeSH terms: Oxaliplatin; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with stage II disease undergoing adjuvant 5-FU treatment will be allocat in chemotherapy-1 group, while stage III patients undergoing combined adjuvant chemotherapy (5FU + Oxaliplatin) will be allocat to the Chemotherapy group -2.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colon cancer; adjuvant chemotherapy; sympathetic nerve activity; peripheral vascular function