Amino Acid DeficiencyNCT05770063
Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer
A study testing amino acid tablet in people with Amino Acid Deficiency and Malnutrition, run by Beijing Chest Hospital.
Trial summary
To investigate whether compound amino acid supplementation can further promote protein synthesis and improve nutritional status for lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amino Acid Deficiency, Malnutrition, Lung Cancer
- What is being tested?
- amino acid tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2023to 30 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NRS2002 >=3 scores
- lung cancer patients
- low albumin or hemoglobin
- informed consent
Who cannot join
- Acute and critical patients;
- Severe liver and kidney dysfunction;
- Patients with gastrointestinal bleeding or intestinal obstruction;
- Pregnant women, lactating women, people with mental illness, and people without independent behavior ability.
About this study
To investigate whether compound amino acid supplementation can further promote protein synthesis and improve nutritional status for lung cancer patients.
- Conditions
- Amino Acid Deficiency, Malnutrition, Lung Cancer
- Being tested
- amino acid tablet
- Medical subject headings
- Malnutrition, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amino acid tabletDietary supplement
multiple essential amino acids supplements
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | compound amino acid supplement Receives: Dietary Supplement: amino acid tablet |
| control group | Placebo comparator | placebo Receives: Dietary Supplement: amino acid tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of albumin
Measured: after 42 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start15 Apr 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amino Acid DeficiencyStudies of the same condition, open and under way.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuo Li, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770063
- Sponsor's protocol ID
- YNLX-2022-011
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT05770063
- Acronym / sponsor ID
- YNLX-2022-011
- Conditions
- Amino Acid Deficiency, Malnutrition, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- 15 Apr 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 15 Mar 2023 (actual)
- 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.
To investigate whether compound amino acid supplementation can further promote protein synthesis and improve nutritional status for lung cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Dietary Supplement: amino acid tabletcompound amino acid supplement |
| control group | Placebo comparator | Dietary Supplement: amino acid tabletplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NRS2002 >=3 scores
- lung cancer patients
- low albumin or hemoglobin
- informed consent
Key exclusion criteria (4 listed)
- Acute and critical patients;
- Severe liver and kidney dysfunction;
- Patients with gastrointestinal bleeding or intestinal obstruction;
- Pregnant women, lactating women, people with mental illness, and people without independent behavior ability.
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 |
|---|---|---|
| amino acid tabletmultiple essential amino acids supplements | Dietary supplement | control group, intervention group |
Primary outcome
Concentration of albumin
Time frame: after 42 days after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing amino acid tablet in people with Amino Acid Deficiency and Malnutrition, run by Beijing Chest Hospital.
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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Concentration of albumin (time frame: after 42 days after the intervention). 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 15 Mar 2023.