Effect of Compound Amino Acid Tablets on Nutritional Stat... | NCT05770063

Studies
Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer

NCT05770063

Sponsor

Beijing Chest Hospital

Status

Unknown status

Last Update Posted

Mar 15, 2023Actual

Enrollment

86Estimated

Phase

Not Applicable

Conditions

Amino Acid Deficiency
Malnutrition
Lung Cancer

Interventions

amino acid tablet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2023Estimated

Primary Completion Date

Jul 30, 2023Estimated

Completion Date

Aug 30, 2023Estimated

First Submitted Date

Feb 21, 2023

First Submission Date that Met QC Criteria

Mar 14, 2023

First Posted Date

Mar 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2023

Last Update Posted Date

Mar 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate whether compound amino acid supplementation can further promote protein synthesis and improve nutritional status for lung cancer patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention group	Experimental	compound amino acid supplement	Dietary Supplement: amino acid tablet
control group	Placebo Comparator	placebo	Dietary Supplement: amino acid tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
amino acid tablet	Dietary Supplement	multiple essential amino acids supplements	control group intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of albumin		after 42 days after the intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000596	Amino Acids

Ancestor Terms

ID	Term
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided