Impact of Branched-chain Amino Acid Supplementation on Quality of Life and Overall Survival in Patients Receiving Liver Directed Therapy for Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
Hepatocellular carcinoma (HCC) is the fifth most common cause of cancer death among men. While several new treatment options have recently become available, they are costly and have a potential for significant, adverse side effects. Many patients diagnosed with HCC also suffer from underlying liver disease, including cirrhosis. As many as 80-90% of patients diagnosed with HCC also have cirrhosis. Protein-energy malnutrition (PEM) in cirrhosis is as high as 65-90% and significantly increases the risk of morbidity and mortality as well as decreased quality of life.
Branched-chain amino acid (BCAA) supplementation has been extensively studied for usefulness in liver disease, specifically to treat hepatic encephalopathy to and preserve and restore muscle mass. Maintenance of liver function and prevention of PEM are essential for improving outcomes in patients with HCC. Branched-chain amino acid supplementation in HCC has been studied extensively in China & Japan with multiple studies showing improvements in liver function, progression-free survival, and overall survival. Additionally, patients in treatment groups have shown improvement in quality of life indicators. However, these results have yet to be replicated in the United States. Branched-chain amino acid supplementation may be a safe, low-cost approach to improve survival, liver function indicators, and quality of life for patients diagnosed with HCC.
In this study, patients with primary HCC will be randomized to either a treatment group, which will receive standard of care and BCAA supplement or to a control group which will receive standard of care and a maltodextrin placebo. Both groups will receive liver-directed therapy including transarterial chemoembolization (TACE) and thermal ablation. All patients will complete a quality of life survey (FACT-Hep) at each visit.
详细描述
Products or Devices to be Studied:
Branched Chain Amino Acid anhydrous blend (1250mg valine, 2500mg leucine, 1250mg isoleucine) Pre-assigned IND number: 140871 Holder of the IND (Richard Marshall, MD)
Purpose of the Study:
Aim: To evaluate the effect of branched-chain amino acid (BCAA) supplementation on progression-free survival and overall survival in patients diagnosed with hepatocellular carcinoma (HCC).
Rationale:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have been diagnosed with HCC and deemed a candidate for nonsurgical local therapy (TACE and/or percutaneous ablation)
- •Have a Child-Pugh score < 6
- •Are at least 18 years of age or older
- •Otherwise healthy adults
- •Provide written consent to participate
排除标准
- •Have a diagnosis of renal failure
- •Have a Child-Pugh score > 6
- •Consume > 60g alcohol intake per day
- •Have been diagnosed with branched-chain ketoaciduria (maple syrup urine disease)
- •Have hepatic encephalopathy
- •Have been diagnosed with a medical condition that warrants a low-protein diet
- •Are currently taking insulin or metformin
- •Pregnant women
- •Younger than 18 years of age
- •Are unable to provide consent
- •Are incarcerated
研究组 & 干预措施
Control Group
The control group will receive current standard of care (locoregional therapy of the liver, serial bloodwork and imaging, serial assessments in clinic), consume a maltodextrin placebo supplement beginning two weeks prior to liver directed therapy and continue supplementation for the following 12 months.
干预措施: maltodextrin (Other)
Intervention Group
In the intervention group, patients will receive current standard of care (locoregional therapy of the liver, serial bloodwork and imaging, serial assessments in clinic) and consume BCAA supplements beginning two weeks prior to liver directed therapy and continue supplementation for the following 12 months.
干预措施: Branch Chain Amino Acid (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to 24 months after enrollment
Overall survival after after Day 0 of study (date of HCC treatment)
次要结局
- Progression Free Survival(Up to 24 months after enrollment)
- Event Free Survival(Up to 24 months after enrollment)
- Quality of life using FACT-Hep(Every 6 months up to 24 months after enrollment)
- Tolerability and Use of BCAA Supplement: use of the supplement as greater than 50% compliance or less than 50% compliance(At every clinic visit up to 24 months after enrollment)