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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02699047
Other study ID # UFSC/04
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 12, 2016
Last updated June 29, 2016
Start date March 2015
Est. completion date July 2017

Study information

Verified date June 2016
Source Universidade Federal de Santa Catarina
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 56
Est. completion date July 2017
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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).
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.

Locations

Country Name City State
Brazil Michel Carlos Mocellin Florianopolis Santa Catarina

Sponsors (2)

Lead Sponsor Collaborator
Universidade Federal de Santa Catarina Centro de Pesquisas Oncológicas

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline and 9 weeks (final moment) No
Primary Cytokines of inflammatory response Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10) Baseline, 5 and 9 weeks No
Primary Body weight Assessment of weight (kg) 5 and 9 weeks No
Primary Body Mass Index (BMI) Assessment of BMI (Kg/m²) baseline, 5 and 9 weeks No
Primary Weight Change Weight change in comparison with the weight at baseline (Kg) baseline, 5 and 9 weeks No
Primary Fat mass Fat mass assessment by electric bioimpedance (kg and %) baseline and 9 weeks No
Primary Lean body mass Lean body mass assessment by electric bioimpedance (kg and %) baseline and 9 weeks No
Primary arm circumference measurement of arm circumference using a inelastic metric tape (cm) baseline, 5 and 9 weeks No
Primary tricipital skinfold measurement of triciptal skinfold using a caliper (mm) baseline, 5 and 9 weeks No
Primary Serum C-reactive protein Serum quantification of C-reactive protein (mg/dL) baseline, 5 and 9 weeks No
Primary Activity of Catalase Quantification of erythrocyte catalase activity Baseline and 9 weeks No
Primary Activity of Glutathione Peroxidase Quantification of erythrocyte glutathione peroxidase activity Baseline and 9 weeks No
Primary Activity of Superoxide Dismutase Quantification of erythrocyte superoxide dismutase activity Baseline and 9 weeks No
Primary Lipid Peroxidation Evaluation of lipid hydroperoxides in plasma and leukocytes Baseline and 9 weeks No
Primary Evaluation of adverse events consequences Evaluation of changes in treatment protocol due to adverse events (hospitalizations, treatment interruption, delay of treatment administration, dose reductions) Baseline and 9 weeks No
Primary Graduation of adverse events Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment Baseline, 5 weeks and 9 weeks No
Primary Tumor Markers Quantification of serum tumor marker CEA and CA19 Baseline and 9 weeks No
Primary Survival Evaluation of survival after 6 months and after one year of recruitment Baseline, 6 months and one year No
Primary Serum albumin Serum quantification of albumin (g/dL) baseline, 5 weeks and 9 weeks No
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