Use of Branched-chain Amino Acids in Cancer Cachexia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in BIA
研究概览
简要总结
Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body mass (LBM) based on body weight in kilograms (kg) and bioelectrical impedance assessment (BIA).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Eastern Cooperative Oncology Group (ECOG) performance status score < 2 and a life expectancy >3 months
- •Participants must have evaluable disease by RECIST 1.1 criteria17
- •At least four (4) weeks from prior major surgery
- •Participants must be cachectic as defined by the guidelines below18
- •>5% weight loss over the past 6 months (in absence of simple starvation); OR
- •BMI <20 and any degree of weight loss >2%; OR
- •Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men <14.6 kg/m²; women <11.4 kg/m²) and weight loss >2%
- •Participants must be anorexic as defined by reporting one of the following symptoms below3
- •Early satiety
- •Nausea/vomiting
- •Taste alterations
- •Smell alterations
- •Meat aversion
排除标准
- •Patients taking Levadopa
- •Patients with amyotrophic lateral sclerosis (ALS)
- •Patients utilizing a percutaneous gastrostomy tube for drainage
- •Patients unable to consume food or beverage orally
- •Patients on any form of parenteral nutrition which contains BCAA.
- •Serious non-healing wound, ulcer, or burn
- •Patients who are pregnant or lactating
- •Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
- •Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
研究组 & 干预措施
Treatment
(arm 1) consume five scoops total per day of Pure Encapsulations Branched Chain Amino Acid powder on an outpatient basis (take 2 scoops both in the morning and afternoon and 1 scoop in the evening)
干预措施: Pure Encapsulations Branched Chain Amino Acid powder (Dietary Supplement)
Control
(arm 2): control group (no BCAAs provided)
干预措施: control group (no BCAAs provided) (Dietary Supplement)
结局指标
主要结局
Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in BIA
时间窗: 12 weeks
Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in bioelectrical impedance assessment (BIA).
Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and LBM based on body weight in kg
时间窗: 12 weeks
Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body mass (LBM) based on body weight in kilograms (kg)
次要结局
- Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI).(12 weeks)
研究者
Jordan Waypa
Jordan Waypa, FNP-C
Western Regional Medical Center