NCT02699047

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

February 12, 2016

Last Update Submit

June 29, 2016

Conditions

Gastrointestinal CancerColorectal CancerStomach Cancer

Keywords

Gastrointestinal cancerFish oilOxidative stressInflammationQuality of lifeNutritional statusColorectal cancerStomach cancerChemotherapypolyunsaturated fatty acids n-3

Outcome Measures

Primary Outcomes (19)

  • 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)

  • Cytokines of inflammatory response

    Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10)

    Baseline, 5 and 9 weeks

  • Body weight

    Assessment of weight (kg)

    5 and 9 weeks

  • Body Mass Index (BMI)

    Assessment of BMI (Kg/m²)

    baseline, 5 and 9 weeks

  • Weight Change

    Weight change in comparison with the weight at baseline (Kg)

    baseline, 5 and 9 weeks

  • Fat mass

    Fat mass assessment by electric bioimpedance (kg and %)

    baseline and 9 weeks

  • Lean body mass

    Lean body mass assessment by electric bioimpedance (kg and %)

    baseline and 9 weeks

  • arm circumference

    measurement of arm circumference using a inelastic metric tape (cm)

    baseline, 5 and 9 weeks

  • tricipital skinfold

    measurement of triciptal skinfold using a caliper (mm)

    baseline, 5 and 9 weeks

  • Serum C-reactive protein

    Serum quantification of C-reactive protein (mg/dL)

    baseline, 5 and 9 weeks

  • Activity of Catalase

    Quantification of erythrocyte catalase activity

    Baseline and 9 weeks

  • Activity of Glutathione Peroxidase

    Quantification of erythrocyte glutathione peroxidase activity

    Baseline and 9 weeks

  • Activity of Superoxide Dismutase

    Quantification of erythrocyte superoxide dismutase activity

    Baseline and 9 weeks

  • Lipid Peroxidation

    Evaluation of lipid hydroperoxides in plasma and leukocytes

    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)

    Baseline and 9 weeks

  • Graduation of adverse events

    Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment

    Baseline, 5 weeks and 9 weeks

  • Tumor Markers

    Quantification of serum tumor marker CEA and CA19

    Baseline and 9 weeks

  • Survival

    Evaluation of survival after 6 months and after one year of recruitment

    Baseline, 6 months and one year

  • Serum albumin

    Serum quantification of albumin (g/dL)

    baseline, 5 weeks and 9 weeks

Study Arms (2)

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

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

Dietary Supplement: Encapsulated Olive oil

Interventions

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).

Fish oil
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.

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michel Carlos Mocellin

Florianópolis, Santa Catarina, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 31060836DERIVED

MeSH Terms

Conditions

Gastrointestinal NeoplasmsColorectal NeoplasmsStomach NeoplasmsInflammation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Professor

Study Record Dates

First Submitted

February 12, 2016

First Posted

March 4, 2016

Study Start

March 1, 2015

Primary Completion

April 1, 2016

Study Completion

July 1, 2017

Last Updated

June 30, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)