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Trial record 18 of 722 for:    colon cancer AND 5-FU

Impact of Adjuvant Chemotherapy in Patients With Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03213444
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Adjuvant Chemotherapy Drug: adjuvant chemotherapy with 5-FU isolated Drug: adjuvant chemotherapy with 5-FU associated with oxaliplatin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Official Title: Impact of Adjuvant Chemotherapy in Cardiovascular Autonomic Regulation in Patients With Colon Cancer
Actual Study Start Date : July 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213444


Locations
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Brazil
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
São Paulo, Brazil, 01.409-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03213444     History of Changes
Other Study ID Numbers: Adjuvant Chemotherapy
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
Colon cancer
adjuvant chemotherapy
sympathetic nerve activity
peripheral vascular function
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs