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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02327819
Other study ID # 0440-14-TLV
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 24, 2014
Last updated December 24, 2014
Start date January 2015

Study information

Verified date December 2014
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Branched-chain amoni acids (BCAA)

non-BCAA protein supplement


Locations

Country Name City State
Israel Clinical Nutrition Unit, Sourasky Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary time until a new liver tumor is found 2 years No
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