Fish oil consumption and its effect on inflammation in patients with leukaemia and lymphomas undergoing chemotherapy

Not Applicable

• Conditions: C04.588.448; Hematological malignancies

• Registration Number: RBR-7q6cqg
• Lead Sponsor: niversidade Federal de Santa Catarina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Aged 16 years old or more; present hematologic malignancy diagnosis, be able to start chemotherapy; present adequate oral intake conditions; accept to participate of anthropometric and biochemical evaluations, indicating your acceptance by signing the Free and Clarified Consent Term. Additionally, individuals under the age of 18,will be included in the study only after signed parental consent.

Exclusion Criteria

Aged less than 16 years old, no legal parental consent if under 18 years old, to be in palliative care; receiving statins and/or some nonsteroidal anti-inflammatory drug; possess any infectious disease diagnosis, be allergic to fish and/or derivatives, have made use of fish oil and/or other supplements containing omega-3 six months before the beginning of the study or being pregnant.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease of the Inflammatory-Nutritional risk indicated by C-reactive protein/Albumin:<br>Calculated by the ratio of the Serum C-reactive protein (mg/L) by the serum albumin (g/dL)<br>Both are determined in serum obtained from blood by an automated biochemistry analyzer. <br>Classification adopted: without risk: <0.4, low risk: 0.4 to 1.2; moderate risk: 1.2 to 2.0; high risk: >2.0<br>After the calculation of the ratio, the intragroup (basal and after nine weeks) and intergroup (control vs. supplemented) values (means or medians) are compared.<br>Additionally, the number of subjects presenting changes in the risk classification are compared between time points and groups of study.

Secondary Outcome Measures

Name	Time	Method
Increase in the Nutritional Risk Index (NRI):<br>Calculated based on the equation: 1.519 x serum albumin (g/dL) + 41.7 x current weight (kg)/usual weight (kg)<br>Serum albumin is determined by an automated colorimetric method, current weight by an electronic platform scale on the days of blood colletion and usual weight (from the last 6 months) is auto-reported <br>The classification adopted: No nutrition risk: >100; Borderline nutrition risk: 99.9-97.5; Mild nutrition risk: 83.5-97.5; Severe nutritional risk: <83.5<br>The intragroup (basal and after nine weeks) and intergroup (control vs. supplemented) values (means or medians) are compared.<br>Additionally, the number of subjects that presenting changes in the risk classification are compared between time points and groups of study<br><br>