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

NCT ID: NCT02327819

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Liver Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BCAA supplement

Branched-chain amino acids supplement, 12 g/day

Group Type ACTIVE_COMPARATOR

Branched-chain amoni acids (BCAA)

Intervention Type DIETARY_SUPPLEMENT

non-BCAA protein supplement

non-BCAA protein supplement

Group Type SHAM_COMPARATOR

non-BCAA protein supplement

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Branched-chain amoni acids (BCAA)

Intervention Type DIETARY_SUPPLEMENT

non-BCAA protein supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Nutrition Unit, Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0440-14-TLV

Identifier Type: -

Identifier Source: org_study_id