Colorectal CancerNCT01575340
Study to Assess the Effect of Consumption of Fish Oil Encapsulated on Inflammatory Markers in Colorectal Cancer
A study testing fish oil encapsuled in people with Colorectal Cancer and Inflammation, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate whether supplementation 2g/day encapsulated fish oil modifies inflammatory markers in individuals with colorectal cancer in chemotherapy Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colorectal Cancer, Inflammation
- What is being tested?
- fish oil encapsuled
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Jul 2012
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years
- Histopathological diagnosis of colorectal cancer
- Beginning of chemotherapy in the target institution
- Agree to participate in the study [signature of IC]
Who cannot join
- Age <19 years
- Being in palliative care
- Inability to oral intake
- Allergic to the fish and fish products
- Owning with hyperlipidemia requiring drug treatment
- Consumption prior to the study of fish oil or supplements containing omega-3 PUFA
- Being in medical treatment with some nonsteroidal anti-inflammatory
- Have some kind of infection
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisas Oncológicas - CEPON
Florianópolis, Santa Catatina, 88034-000
About this study
Official title: Markers of the Inflammatory Response (IL-1β, IL-10, IL-17A and TNF-α) in Patients With Colorectal Cancer in Chemotherapy Supplemented With Fish Oil
The purpose of this study is to evaluate whether supplementation 2g/day encapsulated fish oil modifies inflammatory markers in individuals with colorectal cancer in chemotherapy
Read the detailed description
The study will recruit patients with newly diagnosed colorectal cancer and that has not yet undergone any chemotherapy treatment. Individuals that meet the inclusion criteria are randomized by means of a computer program on two study groups: 1) supplemented Experimental: receive 2g/day supplementation encapsulated fish oil for 9 weeks. 2) No intervention - control: not receive supplementation of fish oil or placebo. Will be assessed the effects of supplementation on the standard profile of cytokine production, nutritional status, and proportion of incorporation of these fatty acids in blood cells (mononuclear and red blood cells).
Blood samples are collected before the start of first chemotherapy and nine weeks later. Supplementation in the experimental group also will start on the first day of chemotherapy.
- Conditions
- Colorectal Cancer, Inflammation
- Being tested
- fish oil encapsuled
- Keywords
- inflammatory markers, colorectal cancer, cytokines, fish oil
- Medical subject headings
- Colorectal Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oil encapsuledDietary supplement
Also called omega-3 encapsuled
2 g/d (4 capsules of 500 mg)for 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| fish oil encapsuled | Experimental | will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks Receives: Dietary Supplement: fish oil encapsuled |
| without supplementation | No intervention | not will receive supplementation or encapsulated fish oil or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in inflammatory markers
will be evaluated cytokines IL-1 beta, IL-10, IL-17A and TNF alpha, and acute phase proteins CRP and Albumin, in baseline that corresponds to the day that the patient will begin chemotherapy and the final moment, which corresponds to 9 weeks counting from the baseline in both groups (supplemented and non-supplemented)
Measured: two months
Secondary outcomes (4)
change in body composition
will estimate the percentage of body fat in each patient through the use of skinfold thickness at baseline and end to study in both groups
Measured: two months
change in nutritional status
will be measured anthropometric measures: weight and height (baseline and end of study) for the classification of nutritional status according to BMI
Measured: two months
Changes in plasma lipid profile
will evaluate the proportion of incorporation of omega-3 fatty acids in plasma
Measured: two months
assessing the risk of inflammatory and nutritional complications
Will be calculated the ratio PCR / albumin, as proposed by Correa et al., 2002, using the cutoff points proposed by the same author for the classification of high, medium, decreased or no risk
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startJul 2011
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina, Centro de Pesquisas Oncológicas de Florianópolis
- Responsible party
- Principal investigator, Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina
- Investigators
- Michel C Mocellin, Master's, Principal investigator, Universidade Federal de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575340
- Sponsor's protocol ID
- 20.179/2010-0
- Status last verified
- Sep 2012
- First submitted
- 5 Oct 2011
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of the Inflammatory Response (IL-1β, IL-10, IL-17A and TNF-α) in Patients With Colorectal Cancer in Chemotherapy Supplemented With Fish Oil
- ClinicalTrials.gov ID
- NCT01575340
- Acronym / sponsor ID
- 20.179/2010-0
- Conditions
- Colorectal Cancer, Inflammation
- Keywords
- inflammatory markers, colorectal cancer, cytokines, fish oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina, Centro de Pesquisas Oncológicas de Florianópolis
- Study start
- Jul 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Apr 2012 (estimated)
- 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 purpose of this study is to evaluate whether supplementation 2g/day encapsulated fish oil modifies inflammatory markers in individuals with colorectal cancer in chemotherapy
Detailed description
The study will recruit patients with newly diagnosed colorectal cancer and that has not yet undergone any chemotherapy treatment. Individuals that meet the inclusion criteria are randomized by means of a computer program on two study groups: 1) supplemented Experimental: receive 2g/day supplementation encapsulated fish oil for 9 weeks. 2) No intervention - control: not receive supplementation of fish oil or placebo. Will be assessed the effects of supplementation on the standard profile of cytokine production, nutritional status, and proportion of incorporation of these fatty acids in blood cells (mononuclear and red blood cells).
Blood samples are collected before the start of first chemotherapy and nine weeks later. Supplementation in the experimental group also will start on the first day of chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fish oil encapsuled | Experimental | Dietary Supplement: fish oil encapsuledwill receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks |
| without supplementation | No intervention | –not will receive supplementation or encapsulated fish oil or placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 19 years
- Histopathological diagnosis of colorectal cancer
- Beginning of chemotherapy in the target institution
- Agree to participate in the study [signature of IC]
Key exclusion criteria (8 listed)
- Age <19 years
- Being in palliative care
- Inability to oral intake
- Allergic to the fish and fish products
- Owning with hyperlipidemia requiring drug treatment
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 |
|---|---|---|
| fish oil encapsuledAlso: omega-3 encapsuled2 g/d (4 capsules of 500 mg)for 9 weeks | Dietary supplement | fish oil encapsuled |
Primary outcome
change in inflammatory markers
Time frame: two months
will be evaluated cytokines IL-1 beta, IL-10, IL-17A and TNF alpha, and acute phase proteins CRP and Albumin, in baseline that corresponds to the day that the patient will begin chemotherapy and the final moment, which corresponds to 9 weeks counting from the baseline in both groups (supplemented and non-supplemented)
4 secondary outcomes
change in body composition
Time frame: two months
change in nutritional status
Time frame: two months
Changes in plasma lipid profile
Time frame: two months
assessing the risk of inflammatory and nutritional complications
Time frame: two 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 6 Sep 2012.
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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.
Michel C Mocellin, Master's principal investigator
Universidade Federal de Santa Catarina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fish oil encapsuled in people with Colorectal Cancer and Inflammation, run by Universidade Federal de Santa Catarina 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 4 inclusion and 8 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 6 Sep 2012. 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?
change in inflammatory markers (time frame: two 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 6 Sep 2012; AzTrials last refreshed its copy on 8 Nov 2026.