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Trial record 15 of 493 for:    Supplement | maltodextrin

Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma (BCAA in HCC)

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ClinicalTrials.gov Identifier: NCT03908255
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
University Medical Center-New Orleans
Information provided by (Responsible Party):
Louisiana State University Health Sciences Center in New Orleans

Brief 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.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Cirrhosis Liver Failure Drug: Branch Chain Amino Acid Other: maltodextrin Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Impact of Branched-chain Amino Acid Supplementation on Quality of Life and Overall Survival in Patients Receiving Liver Directed Therapy for Hepatocellular Carcinoma
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Group
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.
Other: maltodextrin
Placebo

Experimental: Intervention Group
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.
Drug: Branch Chain Amino Acid
Nutritional supplementation
Other Name: Do Vitamins BCAA




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 24 months after enrollment ]
    Overall survival after after Day 0 of study (date of HCC treatment)


Secondary Outcome Measures :
  1. Tolerability and Use of BCAA Supplement: use of the supplement as greater than 50% compliance or less than 50% compliance [ Time Frame: At every clinic visit up to 24 months after enrollment ]
    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.

  2. Progression Free Survival [ Time Frame: Up to 24 months after enrollment ]
    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/)

  3. Event Free Survival [ Time Frame: Up to 24 months after enrollment ]
    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.

  4. Quality of life using FACT-Hep [ Time Frame: Every 6 months up to 24 months after enrollment ]
    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.


Other Outcome Measures:
  1. Child Pugh Score [ Time Frame: At every clinic visit up to 24 months after enrollment ]
    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.

  2. Weight [ Time Frame: At every clinic visit up to 24 months after enrollment ]
    Measurement of weight in both kilograms and pounds

  3. Height [ Time Frame: Every 3 months up to 24 months after enrollment ]
    Height will be measured in inches, centimeters or meters and converted using conversion factors to inches, centimeters or meters at each clinic visit

  4. Body mass index [ Time Frame: Every 3 months up to 24 months after enrollment ]
    Weight and height will be combined to report BMI in kg/m^2

  5. Aspartate aminotransferase [ Time Frame: Every 3 months up to 24 months after enrollment ]
    Serum aspartate aminotransferase in units per liter

  6. Alanine aminotransferase [ Time Frame: Every 3 months up to 24 months after enrollment ]
    Serum alanine aminotransferase in units per liter

  7. Alkaline phosphatase [ Time Frame: Every 3 months up to 24 months after enrollment ]
    Serum alkaline phosphatase in units per liter

  8. Albumin [ Time Frame: Every 3 months up to 24 months after enrollment ]
    Serum albumin measurement in grams per deciliter

  9. Bilirubin [ Time Frame: Every 3 months up to 24 months after enrollment ]
    Serum bilirubin measurement in milligrams per deciliter

  10. Platelet count [ Time Frame: Every 3 months up to 24 months after enrollment ]
    Serum platelet count in thousands per microliter

  11. International normalized ratio (INR) [ Time Frame: Every 3 months up to 24 months after enrollment ]
    Measurement of coagulation (unitless)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908255


Contacts
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Contact: Richard H Marshall, MD 5044536883 rmars1@lsuhsc.edu
Contact: Laura Kerns, RD 7347554111 laura.kerns@lcmchealth.org

Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
University Medical Center-New Orleans
Investigators
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Principal Investigator: Richard H Marshall, MD Louisiana State University Health Sciences Center

Additional Information:
Publications of Results:

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Responsible Party: Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT03908255     History of Changes
Other Study ID Numbers: BCAA in HCC Intervention
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame:

The time frame for data sharing will begin after initial publication and will extend for 5 years.

After this point, data will be purged from secured servers and will no longer be available for sharing.

Access Criteria: A request for data will be made through the principal investigator of this study, who is responsible for data storage. Requests will be made to local Institutional Review Boards prior to de-identified data release.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
branch chain amino acid
nutritional supplement
malnutrition
decompensated liver failure
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Failure
Hepatic Insufficiency
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases