The n-3 fatty acid supplementation in breast tumor patients

Effect of supplementation with n-3 fatty acid on nutritional status, quality of life, immune response and the enzyme fatty acid synthase activity in patients with breast tumors in chemotherapy treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-2b2hqh

Enrollment

Unknown

Registered

2015-12-30

Start date

2012-02-07

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant neoplasm of breast

Interventions

Thirty-eight patients in the experimental group will receive 2 g per day of fish oil concentrate (MaxOmega®). Equal number of patients will be assigned to the control group and will receive 2g per day

Dietary supplement

J02.500.456

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Treatment naïve breast cancer patients with 18 to 70 years of age, with mammographic image classification of BIRADS 4C or above and malignancy confirmed by biopsy results.

Exclusion criteria

Exclusion criteria: Metastasis or reincidiva, pacemaker user, hematologic disease or other blood disorders that affect the laboratory results, inability to communicate verbally and presence of edema.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the nutritional status of patients. We expect to observe maintenance or improvement in the nutritional status in the experimental group, verified by measuring the body mass índex (BMI), evidenced by the difference of at least 10% in the mean delta BMI between the intervention group and the control.	—

Secondary

Measure	Time frame
Secondary outcomes are: 1. Body composition. It is expected that in the experimental group patients maintain or increase lean body mass, assessed by bioelectrical impedance analysis (RJL system), evidenced by the difference of at least 10% in lean body mass (kg) deltas between the intervention group and the control. 2. Immunological and inflammatory biomarkers. It is expected that in the experimental group patients increase CD4+/ CD8+ ratio (assessed by flow cytometry) and reduce serum levels of IL-6 IL-1? and tumor necrosis factor (TNF-alpha) (measured by the immuno enzyme assay ELISA), based on the difference of at least 10% in the deltas of these variables between the intervention group and the control. 3.Enzyme fatty acid synthase. Reduction in the serum level of the enzyme fatty acid synthase (FASN) is expected, evaluated by ELISA immunoassay method, evidenced by the decrease of at least 10% in the delta between the treatment group and control.	—

Measure

Time frame

Secondary outcomes are: 1. Body composition. It is expected that in the experimental group patients maintain or increase lean body mass, assessed by bioelectrical impedance analysis (RJL system), evidenced by the difference of at least 10% in lean body mass (kg) deltas between the intervention group and the control. 2. Immunological and inflammatory biomarkers. It is expected that in the experimental group patients increase CD4+/ CD8+ ratio (assessed by flow cytometry) and reduce serum levels of IL-6 IL-1? and tumor necrosis factor (TNF-alpha) (measured by the immuno enzyme assay ELISA), based on the difference of at least 10% in the deltas of these variables between the intervention group and the control. 3.Enzyme fatty acid synthase. Reduction in the serum level of the enzyme fatty acid synthase (FASN) is expected, evaluated by ELISA immunoassay method, evidenced by the decrease of at least 10% in the delta between the treatment group and control.

—

Countries

Brazil

Contacts

Public ContactElemárcia ;Marina Paixão;Ito

Universidade de Brasília;Universidade de Brasília

e.paixao@yahoo.com.br;marina@unb.br+55(61)3107-1780;+55(61)3107-1780

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 8, 2026