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Fish Oil Supplementation in Gastrointestinal 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: NCT02699047
Recruitment Status : Unknown
Verified June 2016 by Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina.
Recruitment status was:  Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : June 30, 2016
Sponsor:
Collaborator:
Centro de Pesquisas Oncológicas
Information provided by (Responsible Party):
Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Colorectal Cancer Stomach Cancer Dietary Supplement: Encapsuled fish oil Dietary Supplement: Encapsulated Olive oil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gastrointestinal Cancer: Effects of the Fish Oil Intake on Nutritional Status, Quality of Life and Immune and Metabolic Outcomes
Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fish oil
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
Dietary Supplement: Encapsuled fish oil
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).

Placebo Comparator: Control group
3.2 g/day of the olive oil (2 capsules/day) without n-3 polyunsaturated fatty acids
Dietary Supplement: Encapsulated Olive oil
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.




Primary Outcome Measures :
  1. 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.

  2. Cytokines of inflammatory response [ Time Frame: Baseline, 5 and 9 weeks ]
    Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10)

  3. Body weight [ Time Frame: 5 and 9 weeks ]
    Assessment of weight (kg)

  4. Body Mass Index (BMI) [ Time Frame: baseline, 5 and 9 weeks ]
    Assessment of BMI (Kg/m²)

  5. Weight Change [ Time Frame: baseline, 5 and 9 weeks ]
    Weight change in comparison with the weight at baseline (Kg)

  6. Fat mass [ Time Frame: baseline and 9 weeks ]
    Fat mass assessment by electric bioimpedance (kg and %)

  7. Lean body mass [ Time Frame: baseline and 9 weeks ]
    Lean body mass assessment by electric bioimpedance (kg and %)

  8. arm circumference [ Time Frame: baseline, 5 and 9 weeks ]
    measurement of arm circumference using a inelastic metric tape (cm)

  9. tricipital skinfold [ Time Frame: baseline, 5 and 9 weeks ]
    measurement of triciptal skinfold using a caliper (mm)

  10. Serum C-reactive protein [ Time Frame: baseline, 5 and 9 weeks ]
    Serum quantification of C-reactive protein (mg/dL)

  11. Activity of Catalase [ Time Frame: Baseline and 9 weeks ]
    Quantification of erythrocyte catalase activity

  12. Activity of Glutathione Peroxidase [ Time Frame: Baseline and 9 weeks ]
    Quantification of erythrocyte glutathione peroxidase activity

  13. Activity of Superoxide Dismutase [ Time Frame: Baseline and 9 weeks ]
    Quantification of erythrocyte superoxide dismutase activity

  14. Lipid Peroxidation [ Time Frame: Baseline and 9 weeks ]
    Evaluation of lipid hydroperoxides in plasma and leukocytes

  15. 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)

  16. Graduation of adverse events [ Time Frame: Baseline, 5 weeks and 9 weeks ]
    Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment

  17. Tumor Markers [ Time Frame: Baseline and 9 weeks ]
    Quantification of serum tumor marker CEA and CA19

  18. Survival [ Time Frame: Baseline, 6 months and one year ]
    Evaluation of survival after 6 months and after one year of recruitment

  19. Serum albumin [ Time Frame: baseline, 5 weeks and 9 weeks ]
    Serum quantification of albumin (g/dL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

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): NCT02699047


Locations
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Brazil
Michel Carlos Mocellin
Florianopolis, Santa Catarina, Brazil
Sponsors and Collaborators
Universidade Federal de Santa Catarina
Centro de Pesquisas Oncológicas
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erasmo Benicio Santos de Moraes Trindade, Ph.D. Professor, Universidade Federal de Santa Catarina
ClinicalTrials.gov Identifier: NCT02699047    
Other Study ID Numbers: UFSC/04
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina:
Gastrointestinal cancer
Fish oil
Oxidative stress
Inflammation
Quality of life
Nutritional status
Colorectal cancer
Stomach cancer
Chemotherapy
polyunsaturated fatty acids n-3
Additional relevant MeSH terms:
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Colorectal Neoplasms
Gastrointestinal Neoplasms
Stomach Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases