Evaluation of Oral Supplementation With Fish Oil Nutritional Status, Immunity and Inflammation of Patients With Stomach Cancer

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-74s6yx
• Date of registration: 14/09/2015
• Prospective Registration: No
• Primary sponsor: Instituto Nacional de Câncer
• Public title: Evaluation of Oral Supplementation With Fish Oil Nutritional Status, Immunity and Inflammation of Patients With Stomach Cancer
• Scientific title: Impact of Oral supplementation with omega-3 in the Nutritional Status, Immune and Inflammatory Profile of Patients with Gastric Cancer
• Date of first enrolment: 20/07/2015
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-74s6yx
• Study type: Intervention
• Study design: Clinical trial, randomized, controlled, parallel, open, with two arms.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Patricia Moreira Feijó
• Affiliation: Instituto Nacional de Câncer

• Name: Patricia Moreira Feijó
• Affiliation: Instituto Nacional de Câncer

Key inclusion & exclusion criteria

Inclusion criteria: Target sample size is 106 patients.
Patients with gastric cancer.
Patients in pre-treatment (chemo / radiation / surgery).
Female or male patients aged between 20 and 65 years.
Signing of the Informed Consent.
Exclusion criteria: Patients with Chronic Hepatic Insufficiency (CHILD-PUGH C); With HIV Virus or Acquired Immune Deficiency Syndrome (AIDS); Congestive Heart Failure Record; Chronic Kidney Disease; Diabetes Mellitus.
Patients undergoing chemotherapy or radiotherapy already started.
Patients with other cancer diagnosis in up to five years ago.
Patients with focal infection or inflammatory disease.
Patients who refuse to sign the consent form for study participation.
Patients who did not tolerate the use of nutritional supplementation or do not use the supplement as prescribed amount i.e. adhesion to the lower supplementation to 80% prescribed amount.

Age minimum: 20Y
Age maximum: 65Y
Gender: -

Health Condition(s) or Problem(s) studied

gastric Cancer

Intervention(s)

Patients will be divided into 2 groups, an intervention group and a control group.
The intervention group will be composed of 53 patients who will receive the nutritional supplement high caloric and protein liquid formula for oral or enteral nutrition with omega-3. The supplement will be split in two steps of 220ml per day for a period of 30 days, which adds to each patient an additional of 600kcal and 27g protein/day. Before and after supplementation, patients will be assessed for nutritional status, according to food intake (24-hour recall), weight, height, skinfold thickness and bioelectrical impedance. Two blood samples will be carried out (at the first visit and after 30 days) in order to assess the biochemical (albumin and prealbumin), immunological, as CD4, CD8 and CD56 and inflammatory parameters, like CRP and IL-6.
The control group will consist of 53 patients who will receive the nutritional supplement high caloric and protein liquid formula for oral or enteral nutrition without omega-3. The supplement will be split in two steps of 150 ml per day, for a period of 30 days, which adds to each patient an additional of 560kcal and 29g protein/day. Before and after supplementation, patients will be assessed for nutritional status, according to food intake (24-hour recall), weight, height, skinfold thickness and bioelectrical impedance. Two blood samples will be carried out (at the first visit and after 30 days) in order to assess the biochemical (albumin and prealbumin), immunological, as CD4, CD8 and CD56 and inflammatory parameters, like CRP and IL-6.
For both groups, during those 30 days we will do phone contacts to monitor the use of supplements.

Dietary supplement

D10.212.302.380.410

SP6.051.227

Primary Outcome(s)

The weight gain in the 30-day period, verified by weight before and after intervention , on a digital balance, from a variation of at least two kilos between measurements.

Secondary Outcome(s)

The lean mass gain in the 30-day period, verified by bioelectrical impedance before and after intervention from a range of 3% between measurements.

Source(s) of Monetary Support

Instituto Nacional de Câncer

Secondary Sponsor(s)

Instituto Nacional de Câncer