Colon CancerNCT03213444
Impact of Adjuvant Chemotherapy in Patients With Colon Cancer
A study testing adjuvant chemotherapy with 5-FU isolated and adjuvant chemotherapy with 5-FU associated with oxaliplatin in people with Colon Cancer and Adjuvant Chemotherapy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Colon Cancer, Adjuvant Chemotherapy
- What is being tested?
- adjuvant chemotherapy with 5-FU isolated and adjuvant chemotherapy with 5-FU associated with oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scale of Performance Status 0 - 1
- Patients submitted to colectomy for adenocarcinoma of colon stages II and III.
Who cannot join
- Severe pulmonary disease
- Decompensated cardiovascular disease
- Neurological disease
- Insulin-dependent diabetes mellitus
- Dialysis renal insufficiency
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
São Paulo, 01.409-000
About this study
Official title: 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.
Read the 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.
- Conditions
- Colon Cancer, Adjuvant Chemotherapy
- Being tested
- adjuvant chemotherapy with 5-FU isolated, adjuvant chemotherapy with 5-FU associated with oxaliplatin
- Keywords
- Colon cancer, adjuvant chemotherapy, sympathetic nerve activity, peripheral vascular function
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant chemotherapy with 5-FU isolatedDrug
Patients submitted to adjuvant chemotherapy with 5-FU isolated
adjuvant chemotherapy with 5-FU associated with oxaliplatinDrug
Patients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| Quimioterapy 1 | Active comparator | adjuvant chemotherapy with 5-FU isolated Receives: Drug: adjuvant chemotherapy with 5-FU isolated |
| Quimioterapy 2 | Active comparator | adjuvant chemotherapy with 5-FU associated with oxaliplatin Receives: Drug: adjuvant chemotherapy with 5-FU associated with oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac function evaluation
Cardiac function will be assessed by two-dimensional (B-mode) echocardiography, pulsed Doppler
Measured: Change from Baseline cardiac function at 6 months
Secondary outcomes (4)
vascular function evaluation
Vascular function will be assessed by high resolution Doppler ultrasound
Measured: Change from Baseline vascular function at 6 months
autonomic control evaluation
autonomic control will be assessed by microneurography and heart rate variability
Measured: Change from autonomic control at 6 months
functional capacity evaluation
functional capacity will be assessed by cardiopulmonary exercise test
Measured: Change from Baseline functional capacity at 6 months
Proinflammatory cytokines
Proinflammatory cytokines will be assessed by blood evaluations
Measured: Change from Baseline Proinflammatory cytokines at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startJul 2015
- Primary completionJul 2017
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213444
- Sponsor's protocol ID
- Adjuvant Chemotherapy
- Status last verified
- Jul 2016
- First submitted
- 5 Jul 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adjuvant Chemotherapy in Cardiovascular Autonomic Regulation in Patients With Colon Cancer
- ClinicalTrials.gov ID
- NCT03213444
- Acronym / sponsor ID
- Adjuvant Chemotherapy
- Conditions
- Colon Cancer, Adjuvant Chemotherapy
- Keywords
- Colon cancer, adjuvant chemotherapy, sympathetic nerve activity, peripheral vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Quimioterapy 1 | Active comparator | Drug: adjuvant chemotherapy with 5-FU isolatedadjuvant chemotherapy with 5-FU isolated |
| Quimioterapy 2 | Active comparator | Drug: adjuvant chemotherapy with 5-FU associated with oxaliplatinadjuvant chemotherapy with 5-FU associated with oxaliplatin |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scale of Performance Status 0 - 1
- Patients submitted to colectomy for adenocarcinoma of colon stages II and III.
Key exclusion criteria (5 listed)
- Severe pulmonary disease
- Decompensated cardiovascular disease
- Neurological disease
- Insulin-dependent diabetes mellitus
- Dialysis renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adjuvant chemotherapy with 5-FU isolatedPatients submitted to adjuvant chemotherapy with 5-FU isolated | Drug | Quimioterapy 1 |
| adjuvant chemotherapy with 5-FU associated with oxaliplatinPatients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin | Drug | Quimioterapy 2 |
Primary outcome
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
4 secondary outcomes
vascular function evaluation
Time frame: Change from Baseline vascular function at 6 months
autonomic control evaluation
Time frame: Change from autonomic control at 6 months
functional capacity evaluation
Time frame: Change from Baseline functional capacity at 6 months
Proinflammatory cytokines
Time frame: Change from Baseline Proinflammatory cytokines at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adjuvant chemotherapy with 5-FU isolated and adjuvant chemotherapy with 5-FU associated with oxaliplatin in people with Colon Cancer and Adjuvant Chemotherapy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac function evaluation (time frame: Change from Baseline cardiac function at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.