Gastrointestinal Cancer: Effects of the Fish Oil Intake on Nutritional Status, Quality of Life and Immune and Metabolic Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Activity of Glutathione Peroxidase
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Activity of Glutathione Peroxidase
时间窗: Baseline and 9 weeks
Quantification of erythrocyte glutathione peroxidase activity
Fat mass
时间窗: baseline and 9 weeks
Fat mass assessment by electric bioimpedance (kg and %)
Lean body mass
时间窗: baseline and 9 weeks
Lean body mass assessment by electric bioimpedance (kg and %)
arm circumference
时间窗: baseline, 5 and 9 weeks
measurement of arm circumference using a inelastic metric tape (cm)
tricipital skinfold
时间窗: baseline, 5 and 9 weeks
measurement of triciptal skinfold using a caliper (mm)
Serum C-reactive protein
时间窗: baseline, 5 and 9 weeks
Serum quantification of C-reactive protein (mg/dL)
Activity of Catalase
时间窗: Baseline and 9 weeks
Quantification of erythrocyte catalase activity
Change in Quality of life
时间窗: baseline and 9 weeks (final moment)
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.
Cytokines of inflammatory response
时间窗: Baseline, 5 and 9 weeks
Quantification of plasmatic concentration of cytokines (TNF, IL-17A, IL-10)
Body weight
时间窗: 5 and 9 weeks
Assessment of weight (kg)
Body Mass Index (BMI)
时间窗: baseline, 5 and 9 weeks
Assessment of BMI (Kg/m²)
Weight Change
时间窗: baseline, 5 and 9 weeks
Weight change in comparison with the weight at baseline (Kg)
Activity of Superoxide Dismutase
时间窗: Baseline and 9 weeks
Quantification of erythrocyte superoxide dismutase activity
Lipid Peroxidation
时间窗: Baseline and 9 weeks
Evaluation of lipid hydroperoxides in plasma and leukocytes
Evaluation of adverse events consequences
时间窗: Baseline and 9 weeks
Evaluation of changes in treatment protocol due to adverse events (hospitalizations, treatment interruption, delay of treatment administration, dose reductions)
Graduation of adverse events
时间窗: Baseline, 5 weeks and 9 weeks
Graduation of hematological and gastrointestinal adverse events related to chemotherapy treatment
Survival
时间窗: Baseline, 6 months and one year
Evaluation of survival after 6 months and after one year of recruitment
Serum albumin
时间窗: baseline, 5 weeks and 9 weeks
Serum quantification of albumin (g/dL)
Tumor Markers
时间窗: Baseline and 9 weeks
Quantification of serum tumor marker CEA and CA19
次要结局
未报告次要终点
研究者
Erasmo Benicio Santos de Moraes Trindade
Ph.D. Professor
Universidade Federal de Santa Catarina