Primary Liver CancerNCT02327819
The Effect of Branched-chain Amino Acid (BCAA) on the Progression of Primary Liver Cancer
A study testing Branched-chain amoni acids (BCAA) and non-BCAA protein supplement in people with Primary Liver Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Liver Cancer
- What is being tested?
- Branched-chain amoni acids (BCAA) and non-BCAA protein supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed primary liver cancer
- viral or Nonalcoholic Steatohepatitis Cirrhosis
- Cirrhosis rated Child-Pugh A
- liver cancer rated Barcelona Clinic Liver Cancer (BCLC) A
Who cannot join
- Age (over 65)
- liver condition rated Child-Pugh B/C
- GI/Absorption issues
- patients given a treatment before surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Primary Liver Cancer
- Being tested
- Branched-chain amoni acids (BCAA), non-BCAA protein supplement
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched-chain amoni acids (BCAA)Dietary supplement
non-BCAA protein supplementDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| BCAA supplement | Active comparator | Branched-chain amino acids supplement, 12 g/day Receives: Dietary Supplement: Branched-chain amoni acids (BCAA) |
| non-BCAA protein supplement | Sham comparator | non-BCAA protein supplement Receives: Dietary Supplement: non-BCAA protein supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
time until a new liver tumor is found
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327819
- Sponsor's protocol ID
- 0440-14-TLV
- Status last verified
- Dec 2014
- First submitted
- 24 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Branched-chain Amino Acid (BCAA) on the Progression of Primary Liver Cancer
- ClinicalTrials.gov ID
- NCT02327819
- Acronym / sponsor ID
- 0440-14-TLV
- Conditions
- Primary Liver Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCAA supplement | Active comparator | Dietary Supplement: Branched-chain amoni acids (BCAA)Branched-chain amino acids supplement, 12 g/day |
| non-BCAA protein supplement | Sham comparator | Dietary Supplement: non-BCAA protein supplementnon-BCAA protein supplement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed primary liver cancer
- viral or Nonalcoholic Steatohepatitis Cirrhosis
- Cirrhosis rated Child-Pugh A
- liver cancer rated Barcelona Clinic Liver Cancer (BCLC) A
Key exclusion criteria (4 listed)
- Age (over 65)
- liver condition rated Child-Pugh B/C
- GI/Absorption issues
- patients given a treatment before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Branched-chain amoni acids (BCAA) | Dietary supplement | BCAA supplement |
| non-BCAA protein supplement | Dietary supplement | non-BCAA protein supplement |
Primary outcome
time until a new liver tumor is found
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Branched-chain amoni acids (BCAA) and non-BCAA protein supplement in people with Primary Liver Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time until a new liver tumor is found (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.