Back to resultsEffect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer
Primary Purpose
Amino Acid Deficiency, Malnutrition, Lung Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
amino acid tablet
Sponsored by
About this trial
This is an interventional supportive care trial for Amino Acid Deficiency
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
intervention group
control group
Arm Description
compound amino acid supplement
placebo
Outcomes
Primary Outcome Measures
Concentration of albumin
Secondary Outcome Measures
Full Information
NCT ID
NCT05770063
First Posted
February 21, 2023
Last Updated
March 14, 2023
Sponsor
Beijing Chest Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05770063
Brief Title
Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer
Official Title
Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chest Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To investigate whether compound amino acid supplementation can further promote protein synthesis and improve nutritional status for lung cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amino Acid Deficiency, Malnutrition, Lung Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
compound amino acid supplement
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
amino acid tablet
Intervention Description
multiple essential amino acids supplements
Primary Outcome Measure Information:
Title
Concentration of albumin
Time Frame
after 42 days after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer
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