Clinical trial · Interventional
Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma
Impact of Branched-chain Amino Acid Supplementation on Quality of Life and Overall Survival in Patients Receiving Liver Directed Therapy for Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Dr. Marshall left UMC and LSU Health Sciences Center.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Failure | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Branch Chain Amino Acid | Drug | — | UNRESOLVED |
| maltodextrin | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- 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.
- interventionNames
- Other: maltodextrin
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- 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.
- interventionNames
- Drug: Branch Chain Amino Acid
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- RESULTTakeda H, Nishikawa H, Iguchi E, Ohara Y, Sakamoto A, Saito S, Nishijima N, Nasu A, Komekado H, Kita R, Kimura T, Osaki Y. Effect of treatment with branched-chain amino acids during sorafenib therapy for unresectable hepatocellular carcinoma. Hepatol Res. 2014 Mar;44(3):302-12. doi: 10.1111/hepr.12125. Epub 2013 Apr 29. PMID 23607614
- RESULTNojiri S, Fujiwara K, Shinkai N, Iio E, Joh T. Effects of branched-chain amino acid supplementation after radiofrequency ablation for hepatocellular carcinoma: A randomized trial. Nutrition. 2017 Jan;33:20-27. doi: 10.1016/j.nut.2016.07.013. Epub 2016 Aug 8. PMID 27908546
- RESULTImanaka K, Ohkawa K, Tatsumi T, Katayama K, Inoue A, Imai Y, Oshita M, Iio S, Mita E, Fukui H, Yamada A, Nakanishi F, Inada M, Doi Y, Suzuki K, Kaneko A, Marubashi S, Ito Y, Fukui K, Sakamori R, Yakushijin T, Hiramatsu N, Hayashi N, Takehara T; Osaka Liver Forum. Impact of branched-chain amino acid supplementation on survival in patients with advanced hepatocellular carcinoma treated with sorafenib: A multicenter retrospective cohort study. Hepatol Res. 2016 Sep;46(10):1002-10. doi: 10.1111/hepr.12640. Epub 2016 Jan 26. PMID 26690886
- RESULTChen L, Chen Y, Wang X, Li H, Zhang H, Gong J, Shen S, Yin W, Hu H. Efficacy and safety of oral branched-chain amino acid supplementation in patients undergoing interventions for hepatocellular carcinoma: a meta-analysis. Nutr J. 2015 Jul 9;14:67. doi: 10.1186/s12937-015-0056-6. PMID 26155840
- RESULTAu KP, Chan SC, Chok KS, Chan AC, Cheung TT, Ng KK, Lo CM. Child-Pugh Parameters and Platelet Count as an Alternative to ICG Test for Assessing Liver Function for Major Hepatectomy. HPB Surg. 2017;2017:2948030. doi: 10.1155/2017/2948030. Epub 2017 Aug 29. PMID 28951631
- RESULTChernyak V, Fowler KJ, Kamaya A, Kielar AZ, Elsayes KM, Bashir MR, Kono Y, Do RK, Mitchell DG, Singal AG, Tang A, Sirlin CB. Liver Imaging Reporting and Data System (LI-RADS) Version 2018: Imaging of Hepatocellular Carcinoma in At-Risk Patients. Radiology. 2018 Dec;289(3):816-830. doi: 10.1148/radiol.2018181494. Epub 2018 Sep 25.