The control group will receive current standard of care (transarterial chemoembolization 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.

In the intervention group, patients will receive current standard of care (transarterial chemoembolization 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.

Hepatocellular Carcinoma

Cirrhosis

Liver Failure

Branch Chain Amino Acid

maltodextrin

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

Overall survival after after Day 0 of study (date of HCC treatment)

Assess the supplement's tolerability and adherence to branched chain amino acid supplementation schedule by evaluating use of the supplement as greater than 50% compliance or less than 50% compliance.

Growth or metastasis of HCC measured in days after Day 0 of study (date of HCC treatment) using Liver Imaging Reporting and Data System (LI-RADS) 2018 "Threshold growth", "Tumor Viability" criteria (per the American College of Radiology (ACR), https://www.acr.org/-/media/ACR/Files/RADS/LI-RADS/LI-RADS-2018-Core.pdf?la=en)as well as RECIST 1.1 criteria (per the RECIST Working Group, http://recist.eortc.org/recist-1-1-2/)

Evaluate event free survival in days after Day 0 of study (date of HCC treatment). Events include tumor growth, metastasis, portal vein thrombosis, jaundice, hepatic encephalopathy, new onset or worsening ascites, bleeding diathesis requiring admission, death, hospital admission related to liver disease or hepatocellular carcinoma, allergic reaction to supplement or placebo, other disease related to supplement, placebo, hepatocellular carcinoma or advanced liver disease.

Quality of life will be measured objectively by through use of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT Hep), version 4, Questionnaire. This is a 46 question survey that will be given to participants every 6 months to determine their overall quality of life. Participants answer questions related to symptoms experienced in the last 7 days by circling responses that include "Not at all" (0), "A little bit" (1), "Somewhat" (2), "Quite a bit" (3), "Very much" (4) and the numerical score is used to calculate a total score. Higher scores are associated with higher quality of life. Subcategories exist and numerical totals for subcategories (including physical well being, social/family well being, emotional well being, functional well being, and additional concerns) will be used to score specific characteristics. A link is attached as a reference.

The Child Pugh Score, used to measure overall liver health and prognosis of liver disease, will be calculated (after each lab measurement and clinical assessment using serum albumin, bilirubin, international normalized ratio, presence and severity of ascites and presence and severity of hepatic encephalopathy will be assessed using a numeric score assigned to each category. Total scores are a sum of each category and a higher total is associated with a worse prognosis. No subclassifications will be applied. Please see the reference section for a clinical application of this scale.

Measurement of weight in both kilograms and pounds

Height will be measured in inches, centimeters or meters and converted using conversion factors to inches, centimeters or meters at each clinic visit

Weight and height will be combined to report BMI in kg/m^2

Serum aspartate aminotransferase in units per liter

Serum alanine aminotransferase in units per liter

Serum alkaline phosphatase in units per liter

Serum albumin measurement in grams per deciliter

Serum bilirubin measurement in milligrams per deciliter

Serum platelet count in thousands per microliter

Individual participant data may be shared in collaboration with the current investigators for future studies in which branched chain amino acids for treatment of liver disease are studied in a similar manner to this protocol. All collected data may be made available after local Institutional Review Board authorization, de-identification through a secure method of data transfer (encrypted file sharing) and kept on a secure server.

Louisiana State University Health Sciences Center in New Orleans

University Medical Center-New Orleans

This study design will be a double-blinded, randomized clinical control trial in which treatment-naïve patients diagnosed with HCC will be screened at baseline before being 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) at baseline. In the intervention group, patients will receive current standard of care and consume BCAA supplements beginning two weeks prior to liver directed therapy and continue supplementation for the following 12 months. The control group will receive current standard of care, consume a maltodextrin placebo beginning two weeks prior to liver directed therapy and continue supplementation for the following 12 months.

valine/пролив

Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma

Најкомплетната база на податоци за лековити билки поддржана од науката