Impact of Adjuvant Chemotherapy in Patients With Colon Cancer

February 13, 2019 updated by: University of Sao Paulo General Hospital

Impact of Adjuvant Chemotherapy in Cardiovascular Autonomic Regulation 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01.409-000
        • Sociedade Beneficente de Senhoras Hospital Sirio-Libanes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quimioterapy 1
adjuvant chemotherapy with 5-FU isolated
Drug: adjuvant chemotherapy with 5-FU isolated
Patients submitted to adjuvant chemotherapy with 5-FU isolated
Active Comparator: Quimioterapy 2
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 associated with oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline cardiac function at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vascular function evaluation
Time Frame: Change from Baseline vascular function at 6 months
Vascular function will be assessed by high resolution Doppler ultrasound
Change from Baseline vascular function at 6 months
autonomic control evaluation
Time Frame: Change from autonomic control at 6 months
autonomic control will be assessed by microneurography and heart rate variability
Change from autonomic control at 6 months
functional capacity evaluation
Time Frame: Change from Baseline functional capacity at 6 months
functional capacity will be assessed by cardiopulmonary exercise test
Change from Baseline functional capacity at 6 months
Proinflammatory cytokines
Time Frame: Change from Baseline Proinflammatory cytokines at 6 months
Proinflammatory cytokines will be assessed by blood evaluations
Change from Baseline Proinflammatory cytokines at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

July 7, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adjuvant Chemotherapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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