NCT05770063

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

February 21, 2023

Last Update Submit

March 14, 2023

Conditions

Amino Acid DeficiencyMalnutritionLung Cancer

Outcome Measures

Primary Outcomes (1)

  • Concentration of albumin

    after 42 days after the intervention

Study Arms (2)

intervention group

EXPERIMENTAL

compound amino acid supplement

Dietary Supplement: amino acid tablet

control group

PLACEBO COMPARATOR

placebo

Dietary Supplement: amino acid tablet

Interventions

amino acid tabletDIETARY_SUPPLEMENT

multiple essential amino acids supplements

control groupintervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NRS2002 \>=3 scores
  • lung cancer patients
  • low albumin or hemoglobin
  • informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MalnutritionLung Neoplasms

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Beijing Chest Hospital

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 15, 2023

Study Start

April 15, 2023

Primary Completion

July 30, 2023

Study Completion

August 30, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03