Gastrointestinal CancerNCT02699047
Fish Oil Supplementation in Gastrointestinal Cancer
A study testing Encapsuled fish oil and Encapsulated Olive oil in people with Gastrointestinal Cancer and Colorectal Cancer, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
Trial summary
Double-blind, randomized clinical trial to assess the effects of 1,55 g/day of n-3 fatty acids from fish oil concomitant chemotherapy in gastrointestinal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Cancer, Colorectal Cancer, Stomach Cancer
- What is being tested?
- Encapsuled fish oil and Encapsulated Olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Jul 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with age between 18 to 70 y.
- Histopathological diagnosis of gastric cancer, or colorectal or anal canal or intestinal cancer
- Ability to start chemotherapy in institution (CEPON)
- Performance status <= 2
Who cannot join
- Prior chemotherapy
- Inability to oral intake
- diagnosis of infectious or inflammatory disease or diabetes
- Allergy to fish and / or derivatives,
- Pregnant,
- Treatment with statins or anti-inflammatories drugs
Show all 12Show fewer
- Intake of fish oil and/or another supplement containing omega-3 or other polyunsaturated fatty acid in the six months prior their inclusion in the study
- Continued use of supplements containing antioxidants
- Patients in palliative care
- without cognitive ability to perform the study protocol
- Enrolled in studies with new drugs
- Hospitalized patients at recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastrointestinal Cancer: Effects of the Fish Oil Intake on Nutritional Status, Quality of Life and Immune and Metabolic Outcomes
Double-blind, randomized clinical trial to assess the effects of 1,55 g/day of n-3 fatty acids from fish oil concomitant chemotherapy in gastrointestinal cancer.
Read the detailed description
This study will be divided into three stages defined as: baseline (T0), middle moment (T1) and final moment (T2). At baseline, will be performer the patients identification, clinical data collection, assessment of anthropometric data and body composition, blood sample collection and questionnaires application for individuals allocated into two groups (Fish Oil Group and Placebo Group). The Fish Oil Group (GOP) will receive fish oil capsules and the placebo group (GP) will receive capsules containing olive oil, both also will receive consumption guidelines.
The list of randomization was generated by a computer program and was divided by cancer localization and gender. The researchers involved with the recruitment had access only to randomization list containing codes. The codes were distributed sequentially.
The baseline is the day of first chemotherapy. In the middle moment, five weeks after the start of study, new blood collection, questionnaires and measurement of anthropometric data will be performed. At the final moment, nine weeks after baseline, last blood collection, questionnaires and measurement of anthropometric data and body composition of fish oil and placebo groups will be performed, and will feature the end of the capsules consumption.
After 6 months and 1 year after the initiation of chemotherapy and supplementation with fish oil or placebo, survival data will be collected.
Throughout the monitoring period, the researcher and collaborators will maintain contact with the individuals included. The contact will be made in CEPON, where they receive chemotherapy, and by telephone.
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer, Stomach Cancer
- Being tested
- Encapsuled fish oil, Encapsulated Olive oil
- Keywords
- Gastrointestinal cancer, Fish oil, Oxidative stress, Inflammation, Quality of life, Nutritional status, Colorectal cancer, Stomach cancer, Chemotherapy, polyunsaturated fatty acids n-3
- Medical subject headings
- Gastrointestinal Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encapsuled fish oilDietary supplement
Fish oil extracted from sardine, mackerel and anchovy. Nutritional information per capsule: Kcal: 13; protein: 0.35g; Total Fats: 1.25g; Saturated fat: 0g; polyunsaturated fat: 0.75g; EPA: 0.5g; DHA: 0.25g; Cholesterol: 0g. The supplement was provided in gelatinous capsule with antioxidant (tocopherols).
Encapsulated Olive oilDietary supplement
Extra virgin olive oil. Nutritional information per capsule: Kcal: 10; protein: 0.35g; Total Fats: 1g; Saturated fat: 0.1 g; monounsaturated fat: 0.75g; polyunsaturated fat: 0.1g; EPA: 0g; DHA: 0g; oleic acid: 0.65g; Cholesterol: 0g. The supplement was provided in gelatinous capsule without antioxidants.
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Experimental | 3.6 g/day of the encapsulated fish oil (2 capsules/day) providing 1.55 g/d of the n-3 polyunsaturated fatty acids (EPA and DHA) during 9 weeks Receives: Dietary Supplement: Encapsuled fish oil |
| Control group | Placebo comparator | 3.2 g/day of the olive oil (2 capsules/day) without n-3 polyunsaturated fatty acids Receives: Dietary Supplement: Encapsulated Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life
Application by interview of the EORTC QOL questionnaires: QLQ-C30 v. 3.0; CRC-29 and STO22. The change was observed by increase ou decrease in overall score of the scales.
Measured: baseline and 9 weeks (final moment)
Cytokines of inflammatory response
Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10)
Measured: Baseline, 5 and 9 weeks
Body weight
Assessment of weight (kg)
Measured: 5 and 9 weeks
Body Mass Index (BMI)
Assessment of BMI (Kg/m²)
Measured: baseline, 5 and 9 weeks
Weight Change
Weight change in comparison with the weight at baseline (Kg)
Measured: baseline, 5 and 9 weeks
Fat mass
Fat mass assessment by electric bioimpedance (kg and %)
Measured: baseline and 9 weeks
Lean body mass
Lean body mass assessment by electric bioimpedance (kg and %)
Measured: baseline and 9 weeks
arm circumference
measurement of arm circumference using a inelastic metric tape (cm)
Measured: baseline, 5 and 9 weeks
tricipital skinfold
measurement of triciptal skinfold using a caliper (mm)
Measured: baseline, 5 and 9 weeks
Serum C-reactive protein
Serum quantification of C-reactive protein (mg/dL)
Measured: baseline, 5 and 9 weeks
Activity of Catalase
Quantification of erythrocyte catalase activity
Measured: Baseline and 9 weeks
Activity of Glutathione Peroxidase
Quantification of erythrocyte glutathione peroxidase activity
Measured: Baseline and 9 weeks
Activity of Superoxide Dismutase
Quantification of erythrocyte superoxide dismutase activity
Measured: Baseline and 9 weeks
Lipid Peroxidation
Evaluation of lipid hydroperoxides in plasma and leukocytes
Measured: Baseline and 9 weeks
Evaluation of adverse events consequences
Evaluation of changes in treatment protocol due to adverse events (hospitalizations, treatment interruption, delay of treatment administration, dose reductions)
Measured: Baseline and 9 weeks
Graduation of adverse events
Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment
Measured: Baseline, 5 weeks and 9 weeks
Tumor Markers
Quantification of serum tumor marker CEA and CA19
Measured: Baseline and 9 weeks
Survival
Evaluation of survival after 6 months and after one year of recruitment
Measured: Baseline, 6 months and one year
Serum albumin
Serum quantification of albumin (g/dL)
Measured: baseline, 5 weeks and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Pesquisas Oncológicas
- Responsible party
- Principal investigator, Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699047
- Sponsor's protocol ID
- UFSC/04
- Status last verified
- Jun 2016
- First submitted
- 12 Feb 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Camargo CQ, Mocellin MC, Brunetta HS, Chagas TR, Fabre MES, Trindade EBSM, Silva ELD, Nunes EA. Fish oil decreases the severity of treatment-related adverse events in gastrointestinal cancer patients undergoing chemotherapy: A randomized, placebo-controlled, triple-blind clinical trial. Clin Nutr ESPEN. 2019 Jun;31:61-70. doi: 10.1016/j.clnesp.2019.02.015. Epub 2019 Mar 14.
PubMed 31060836
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Cancer: Effects of the Fish Oil Intake on Nutritional Status, Quality of Life and Immune and Metabolic Outcomes
- ClinicalTrials.gov ID
- NCT02699047
- Acronym / sponsor ID
- UFSC/04
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer, Stomach Cancer
- Keywords
- Gastrointestinal cancer, Fish oil, Oxidative stress, Inflammation, Quality of life, Nutritional status, Colorectal cancer, Stomach cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Collaborators
- Centro de Pesquisas Oncológicas
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 4 Mar 2016 (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.
Double-blind, randomized clinical trial to assess the effects of 1,55 g/day of n-3 fatty acids from fish oil concomitant chemotherapy in gastrointestinal cancer.
Detailed description
This study will be divided into three stages defined as: baseline (T0), middle moment (T1) and final moment (T2). At baseline, will be performer the patients identification, clinical data collection, assessment of anthropometric data and body composition, blood sample collection and questionnaires application for individuals allocated into two groups (Fish Oil Group and Placebo Group). The Fish Oil Group (GOP) will receive fish oil capsules and the placebo group (GP) will receive capsules containing olive oil, both also will receive consumption guidelines.
The list of randomization was generated by a computer program and was divided by cancer localization and gender. The researchers involved with the recruitment had access only to randomization list containing codes. The codes were distributed sequentially.
The baseline is the day of first chemotherapy. In the middle moment, five weeks after the start of study, new blood collection, questionnaires and measurement of anthropometric data will be performed. At the final moment, nine weeks after baseline, last blood collection, questionnaires and measurement of anthropometric data and body composition of fish oil and placebo groups will be performed, and will feature the end of the capsules consumption.
After 6 months and 1 year after the initiation of chemotherapy and supplementation with fish oil or placebo, survival data will be collected.
Throughout the monitoring period, the researcher and collaborators will maintain contact with the individuals included. The contact will be made in CEPON, where they receive chemotherapy, and by telephone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Experimental | Dietary Supplement: Encapsuled fish oil3.6 g/day of the encapsulated fish oil (2 capsules/day) providing 1.55 g/d of the n-3 polyunsaturated fatty acids (EPA and DHA) during 9 weeks |
| Control group | Placebo comparator | Dietary Supplement: Encapsulated Olive oil3.2 g/day of the olive oil (2 capsules/day) without n-3 polyunsaturated fatty acids |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals with age between 18 to 70 y.
- Histopathological diagnosis of gastric cancer, or colorectal or anal canal or intestinal cancer
- Ability to start chemotherapy in institution (CEPON)
- Performance status <= 2
Key exclusion criteria (12 listed)
- Prior chemotherapy
- Inability to oral intake
- diagnosis of infectious or inflammatory disease or diabetes
- Allergy to fish and / or derivatives,
- Pregnant,
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 |
|---|---|---|
| Encapsuled fish oilFish oil extracted from sardine, mackerel and anchovy. Nutritional information per capsule: Kcal: 13; protein: 0.35g; Total Fats: 1.25g; Saturated fat: 0g; polyunsaturated fat: 0.75g; EPA: 0.5g; DHA: 0.25g; Cholesterol: 0g. The supplement was provided in gelatinous capsule with antioxidant (tocopherols). | Dietary supplement | Fish oil |
| Encapsulated Olive oilExtra virgin olive oil. Nutritional information per capsule: Kcal: 10; protein: 0.35g; Total Fats: 1g; Saturated fat: 0.1 g; monounsaturated fat: 0.75g; polyunsaturated fat: 0.1g; EPA: 0g; DHA: 0g; oleic acid: 0.65g; Cholesterol: 0g. The supplement was provided in gelatinous capsule without antioxidants. | Dietary supplement | Control group |
Primary outcome
Change in Quality of life
Time frame: baseline and 9 weeks (final moment)
Application by interview of the EORTC QOL questionnaires: QLQ-C30 v. 3.0; CRC-29 and STO22. The change was observed by increase ou decrease in overall score of the scales.
Cytokines of inflammatory response
Time frame: Baseline, 5 and 9 weeks
Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10)
Body weight
Time frame: 5 and 9 weeks
Assessment of weight (kg)
Body Mass Index (BMI)
Time frame: baseline, 5 and 9 weeks
Assessment of BMI (Kg/m²)
Weight Change
Time frame: baseline, 5 and 9 weeks
Weight change in comparison with the weight at baseline (Kg)
Fat mass
Time frame: baseline and 9 weeks
Fat mass assessment by electric bioimpedance (kg and %)
Lean body mass
Time frame: baseline and 9 weeks
Lean body mass assessment by electric bioimpedance (kg and %)
arm circumference
Time frame: baseline, 5 and 9 weeks
measurement of arm circumference using a inelastic metric tape (cm)
tricipital skinfold
Time frame: baseline, 5 and 9 weeks
measurement of triciptal skinfold using a caliper (mm)
Serum C-reactive protein
Time frame: baseline, 5 and 9 weeks
Serum quantification of C-reactive protein (mg/dL)
Activity of Catalase
Time frame: Baseline and 9 weeks
Quantification of erythrocyte catalase activity
Activity of Glutathione Peroxidase
Time frame: Baseline and 9 weeks
Quantification of erythrocyte glutathione peroxidase activity
Activity of Superoxide Dismutase
Time frame: Baseline and 9 weeks
Quantification of erythrocyte superoxide dismutase activity
Lipid Peroxidation
Time frame: Baseline and 9 weeks
Evaluation of lipid hydroperoxides in plasma and leukocytes
Evaluation of adverse events consequences
Time frame: Baseline and 9 weeks
Evaluation of changes in treatment protocol due to adverse events (hospitalizations, treatment interruption, delay of treatment administration, dose reductions)
Graduation of adverse events
Time frame: Baseline, 5 weeks and 9 weeks
Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment
Tumor Markers
Time frame: Baseline and 9 weeks
Quantification of serum tumor marker CEA and CA19
Survival
Time frame: Baseline, 6 months and one year
Evaluation of survival after 6 months and after one year of recruitment
Serum albumin
Time frame: baseline, 5 weeks and 9 weeks
Serum quantification of albumin (g/dL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Derived from this study: PubMed 31060836Camargo CQ, Mocellin MC, Brunetta HS, Chagas TR, Fabre MES, Trindade EBSM, Silva ELD, Nunes EA. Fish oil decreases the severity of treatment-related adverse events in gastrointestinal cancer patients undergoing chemotherapy: A randomized, placebo-controlled, triple-blind clinical trial. Clin Nutr ESPEN. 2019 Jun;31:61-70. doi: 10.1016/j.clnesp.2019.02.015. Epub 2019 Mar 14.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
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 Encapsuled fish oil and Encapsulated Olive oil in people with Gastrointestinal Cancer and Colorectal Cancer, 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 12 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: status not confirmed, as of the sponsor's last update on 30 Jun 2016. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 Quality of life (time frame: baseline and 9 weeks (final moment)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02699047, which also lists 1 linked publication.
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 30 Jun 2016.