NCT02327819

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

December 24, 2014

Last Update Submit

December 24, 2014

Conditions

Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • time until a new liver tumor is found

    2 years

Study Arms (2)

BCAA supplement

ACTIVE COMPARATOR

Branched-chain amino acids supplement, 12 g/day

Dietary Supplement: Branched-chain amoni acids (BCAA)

non-BCAA protein supplement

SHAM COMPARATOR

non-BCAA protein supplement

Dietary Supplement: non-BCAA protein supplement

Interventions

Branched-chain amoni acids (BCAA)DIETARY_SUPPLEMENT
BCAA supplement
non-BCAA protein supplementDIETARY_SUPPLEMENT
non-BCAA protein supplement

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed primary liver cancer
  • viral or Nonalcoholic Steatohepatitis Cirrhosis
  • Cirrhosis rated Child-Pugh A
  • liver cancer rated Barcelona Clinic Liver Cancer (BCLC) A

You may not qualify if:

  • Age (over 65)
  • liver condition rated Child-Pugh B/C
  • GI/Absorption issues
  • patients given a treatment before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Unit, Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2014

First Posted

December 30, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

IL(1)