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Completed

NCT Number: NCT03213444

Impact of Adjuvant Chemotherapy in Patients With Colon Cancer

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

São Paulo, 01.409-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adjuvant chemotherapy with 5-FU isolated

Drug

Patients submitted to adjuvant chemotherapy with 5-FU isolated

adjuvant chemotherapy with 5-FU associated with oxaliplatin

Drug

Patients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin

Primary outcomes

  1. cardiac function evaluation

    Time frame: Change from Baseline cardiac function at 6 months

    Cardiac function will be assessed by two-dimensional (B-mode) echocardiography, pulsed Doppler

Secondary outcomes

  1. vascular function evaluation

    Time frame: Change from Baseline vascular function at 6 months

    Vascular function will be assessed by high resolution Doppler ultrasound

  2. autonomic control evaluation

    Time frame: Change from autonomic control at 6 months

    autonomic control will be assessed by microneurography and heart rate variability

  3. functional capacity evaluation

    Time frame: Change from Baseline functional capacity at 6 months

    functional capacity will be assessed by cardiopulmonary exercise test

  4. Proinflammatory cytokines

    Time frame: Change from Baseline Proinflammatory cytokines at 6 months

    Proinflammatory cytokines will be assessed by blood evaluations

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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