Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition, Muscle Strength and Concentration of Vascular Endothelial Growth Factor (VEGF) in Patients With Actue Myeloid Leukemia (AML) During the Hospital Stay
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Effect of use of hyperproteic, hypercaloric enteral formula in body composition and VEGF
研究概览
简要总结
A randomized controlled clinical trial in two groups of supplementation with high protein enteral formula and a normocaloric enteral formula in two groups of 37 patients .
详细描述
Patients with acute myeloid leukemia have a high risk of suffering sarcopenia, which decreases the oncology therapy clinical response, functional ability and quality of life. Chemotherapy is used in these patients, some of them inhibit angiogenesis and act in an important way in physiological processes of muscle anabolism. The vascular endothelial growth factor (VEGF) and its receptors (VEGFR) play a crucial role in both normal and malignant angiogenesis. Activation of the VEGF pathway leads to endothelial cell activation, proliferation and survival.
The objective of this study is to compare the effect of the use of a high protein, high energy enteral with omega 3 formula (Supportan DKN) against a standard enteral formula (Fresubin® Original DRINK) on body composition, days of hospital stay, quality of life, associated muscular strength with levels of VEGF in patients with acute myeloid leukemia during induction chemotherapy.
An open clinical trial was designed, in which a group of patients will receive, as part of their nutritional requirements a hyperproteic hyperenergetic enteral formula versus standard formula during the 21 days of the first cycle of antineoplastic treatment. We will measure body composition, muscle strength and serum concentrations of VEGFR in both groups to be able to compare its effect.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a confirmed diagnosis of AML
- •Tolerance to oral feeding
- •Induction Chemotherapy
- •Patients with nutritional risk of positive malnutrition (Score +3 NRS).
- •Candidates to receive enteral nutrition, as well as chemotherapy according to medical indications.
- •Life expectancy greater than a week and with the possibility of starting oncological treatment. Have informed consent obtained by the patient prior to randomization
排除标准
- •Geriatric patients (> 60 years)
- •Patients with acute gastrointestinal bleeding, ileus and shock
- •History of recurrence of neoplasm
- •Renal failure
- •Atrophy of the gastrointestinal mucosa
- •Central nervous system disease,
- •impaired cardiac function.
- •Elimination criteria:
- •Lack of follow up Incomplete data. Insufficient amount of genetic material to perform the determination of the VEGF material.
- •Absence of the determination of the levels of VEGF prior to the start of oncological therapy.
研究组 & 干预措施
Hyperproteic, hypercaloric formula
Each patient will receive 2 bottles per day of Supportan DKN during the hospital stay (nutritional contribution: 600 kcal and 40 g of protein).
干预措施: Experimental group (Dietary Supplement)
Standard formula
Each patient will receive 2 cans or bottles per day of Fresubin® Original DRINK (nutritional contribution: 474.2 kcal and 17.6 g of protein).
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
Effect of use of hyperproteic, hypercaloric enteral formula in body composition and VEGF
时间窗: 21 days
The aim of this study is to compare the effect of the use of a hyperproteic hypercaloric enteral formula (Supportan DKN.) With a standard enteral formula (Fresubin® Original DRINK) in patients with AML during antineoplastic treatment.
次要结局
- Late mortality(1 year)
- Evaluation of the quality of life at the beginning and after the intervention.(21 days)
- Levels of VEGF(2 years)
- Body composition: phase angle(21 days)
- Body composition fat mass(21 days)
- Body compositition: fat-free mass(21 days)
- Early mortality(21 days)
- SARC-F(21 days)
- Length of stay(It depends of the patients health condition)
- Changes in nutritional status during oncological therapy(21 days)
- Early biochemical recovery values(28 days)
- Response to induction chemotherapy.(28 days)
研究者
Dr. Vanessa Fuchs Tarlovsky
Principal Investigator
Hospital General de Mexico