Impact of Adjuvant Chemotherapy in Patients With Colon Cancer
Primary Purpose
Colon Cancer, Adjuvant Chemotherapy
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
adjuvant chemotherapy with 5-FU isolated
adjuvant chemotherapy with 5-FU associated with oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring Colon cancer, adjuvant chemotherapy, sympathetic nerve activity, peripheral vascular function
Eligibility Criteria
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
Sites / Locations
- Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Quimioterapy 1
Quimioterapy 2
Arm Description
adjuvant chemotherapy with 5-FU isolated
adjuvant chemotherapy with 5-FU associated with oxaliplatin
Outcomes
Primary Outcome Measures
cardiac function evaluation
Cardiac function will be assessed by two-dimensional (B-mode) echocardiography, pulsed Doppler
Secondary Outcome Measures
vascular function evaluation
Vascular function will be assessed by high resolution Doppler ultrasound
autonomic control evaluation
autonomic control will be assessed by microneurography and heart rate variability
functional capacity evaluation
functional capacity will be assessed by cardiopulmonary exercise test
Proinflammatory cytokines
Proinflammatory cytokines will be assessed by blood evaluations
Full Information
NCT ID
NCT03213444
First Posted
July 5, 2017
Last Updated
February 13, 2019
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03213444
Brief Title
Impact of Adjuvant Chemotherapy in Patients With Colon Cancer
Official Title
Impact of Adjuvant Chemotherapy in Cardiovascular Autonomic Regulation in Patients With Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Adjuvant Chemotherapy
Keywords
Colon cancer, adjuvant chemotherapy, sympathetic nerve activity, peripheral vascular function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quimioterapy 1
Arm Type
Active Comparator
Arm Description
adjuvant chemotherapy with 5-FU isolated
Arm Title
Quimioterapy 2
Arm Type
Active Comparator
Arm Description
adjuvant chemotherapy with 5-FU associated with oxaliplatin
Intervention Type
Drug
Intervention Name(s)
adjuvant chemotherapy with 5-FU isolated
Intervention Description
Patients submitted to adjuvant chemotherapy with 5-FU isolated
Intervention Type
Drug
Intervention Name(s)
adjuvant chemotherapy with 5-FU associated with oxaliplatin
Intervention Description
Patients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin
Primary Outcome Measure Information:
Title
cardiac function evaluation
Description
Cardiac function will be assessed by two-dimensional (B-mode) echocardiography, pulsed Doppler
Time Frame
Change from Baseline cardiac function at 6 months
Secondary Outcome Measure Information:
Title
vascular function evaluation
Description
Vascular function will be assessed by high resolution Doppler ultrasound
Time Frame
Change from Baseline vascular function at 6 months
Title
autonomic control evaluation
Description
autonomic control will be assessed by microneurography and heart rate variability
Time Frame
Change from autonomic control at 6 months
Title
functional capacity evaluation
Description
functional capacity will be assessed by cardiopulmonary exercise test
Time Frame
Change from Baseline functional capacity at 6 months
Title
Proinflammatory cytokines
Description
Proinflammatory cytokines will be assessed by blood evaluations
Time Frame
Change from Baseline Proinflammatory cytokines at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
City
São Paulo
ZIP/Postal Code
01.409-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Adjuvant Chemotherapy in Patients With Colon Cancer
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