- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770063
Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer
March 14, 2023 updated by: Zhuo Li, Beijing Chest Hospital
To investigate whether compound amino acid supplementation can further promote protein synthesis and improve nutritional status for lung cancer patients.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
86
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- NRS2002 >=3 scores
- lung cancer patients
- low albumin or hemoglobin
- informed consent
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control group
placebo
|
multiple essential amino acids supplements
|
Experimental: intervention group
compound amino acid supplement
|
multiple essential amino acids supplements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concentration of albumin
Time Frame: after 42 days after the intervention
|
after 42 days after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 15, 2023
Primary Completion (Anticipated)
July 30, 2023
Study Completion (Anticipated)
August 30, 2023
Study Registration Dates
First Submitted
February 21, 2023
First Submitted That Met QC Criteria
March 14, 2023
First Posted (Actual)
March 15, 2023
Study Record Updates
Last Update Posted (Actual)
March 15, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YNLX-2022-011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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