The Effect of Branched-chain Amino Acid (BCAA) on the Progression of Primary Liver Cancer

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02327819
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

Supplementation of BCAA found to reduce the risk of developing liver cancer, but the affect of BCAA on existing liver cancer is unknown.

The participants (post curative intent surgery) will be supplemented with either BCAA/non-BCAA-enriched protein supplement. The intervantion will go on for 2 years or until a new liver tumor is found.

Condition or Disease	Intervention/Treatment	Phase
Primary Liver Cancer	Dietary Supplement: Branched-chain amoni acids (BCAA); Dietary Supplement: non-BCAA protein supplement	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BCAA supplement Branched-chain amino acids supplement, 12 g/day	Dietary Supplement: Branched-chain amoni acids (BCAA)
Sham Comparator: non-BCAA protein supplement non-BCAA protein supplement	Dietary Supplement: non-BCAA protein supplement

Outcome Measures

Primary Outcome Measures

1. time until a new liver tumor is found [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosed primary liver cancer

• viral or Nonalcoholic Steatohepatitis Cirrhosis

• Cirrhosis rated Child-Pugh A

• liver cancer rated Barcelona Clinic Liver Cancer (BCLC) A

Exclusion Criteria:

• Age (over 65)

• liver condition rated Child-Pugh B/C

• GI/Absorption issues

• patients given a treatment before surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Nutrition Unit, Sourasky Medical Center	Tel Aviv		Israel	64239

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT02327819
• Other Study ID Numbers: 0440-14-TLV
• First Posted: Dec 30, 2014
• Last Update Posted: Dec 30, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Liver Neoplasms

Study Results

No Results Posted as of Dec 30, 2014