Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Louisiana State University Health Sciences Center in New Orleans