Effect of Omega-3 Supplementation on Body Composition, Functional Capacity, Inflammatory Profile and Quality of Life in Cervix Cancer Patients Undergoing Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Body composition
研究概览
简要总结
Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could potentially maintain body weight in cancer patients undergoing intensive treatment.
The investigators aims in this study is to evaluate the effect of omega-3 supplementation on body composition, functional capacity, inflammatory profile and quality of life in cervix cancer patients undergoing chemoradiotherapy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cervix cancer at FIGO stage II and III
- •Chemoradiotherapy treatment proposal (cisplatin + radiotherapy)
- •Nutritional diagnosis of pre-cachexia ou cachexia
排除标准
- •metastasis (FIGO stage IV)
- •Nutritional diagnosis of refractary cachexia
结局指标
主要结局
Change in Body composition
时间窗: 45 days
Change from baseline body composition assessed by computed tomography scans before and at the end of chemotherapy treatment (45 day after the first chemotherapy)
次要结局
- Change in INF-gama serum levels(45 days)
- Change in membrane incorporation of non-esterified fatty acids(45 days)
- Change in handgrip strength(45 days)
- Change in IL-6 serum levels(45 days)
- Change in IL-1 serum levels(45 days)
- Change in TNF-alfa serum levels(45 days)
- Change in functional capacity (30 second stand chair test)(45 days)
- chemoradiotherapy toxicity(15 and 45 days)
- Change in Quality of life(45 days)
研究者
Gabriela Villaça Chaves
PhD, Researcher at Brazilian National Cancer Institute
Brazilian National Cancer Institute