Impact of Adjuvant Chemotherapy in Patients With Colon Cancer

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213444
• Other study ID #: Adjuvant Chemotherapy
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: February 2019

Study information

• Verified date: July 2016
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2019
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Scale of Performance Status 0 - 1

• Patients submitted to colectomy for adenocarcinoma of colon stages II and III.

Exclusion Criteria:

• Severe pulmonary disease

• Decompensated cardiovascular disease

• Neurological disease

• Insulin-dependent diabetes mellitus

• Dialysis renal insufficiency

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• adjuvant chemotherapy with 5-FU isolated
Patients submitted to adjuvant chemotherapy with 5-FU isolated
• adjuvant chemotherapy with 5-FU associated with oxaliplatin
Patients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin

Locations

Country	Name	City	State
Brazil	Sociedade Beneficente de Senhoras Hospital Sírio-Libanês	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac function evaluation	Cardiac function will be assessed by two-dimensional (B-mode) echocardiography, pulsed Doppler	Change from Baseline cardiac function at 6 months
Secondary	vascular function evaluation	Vascular function will be assessed by high resolution Doppler ultrasound	Change from Baseline vascular function at 6 months
Secondary	autonomic control evaluation	autonomic control will be assessed by microneurography and heart rate variability	Change from autonomic control at 6 months
Secondary	functional capacity evaluation	functional capacity will be assessed by cardiopulmonary exercise test	Change from Baseline functional capacity at 6 months
Secondary	Proinflammatory cytokines	Proinflammatory cytokines will be assessed by blood evaluations	Change from Baseline Proinflammatory cytokines at 6 months