Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Collaborator: University Medical Center-New Orleans
• Treatments: Vitamins

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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