NCT05937074

Brief Summary

This goal of this study is to describe how unintentional weight loss influences fasting and post-prandial metabolic flexibility in participants with advanced non-small cell lung cancer.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress95%
Jul 2023Jun 2026

First Submitted

Initial submission to the registry

June 23, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 18, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

June 23, 2023

Last Update Submit

July 1, 2025

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

  • Respiratory quotient

    The respiratory quotient will be measured by indirect calorimetry before and after consumption of a liquid mixed meal

    Difference between pre- to post-prandial conditions over four hours

Interventions

Weight loss (%)OTHER

Change in body weight from cancer diagnosis to study enrollment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include participants with non-small-cell lung cancer with varying degrees of weight loss.

You may qualify if:

  • Age greater than or equal to 18 years
  • Diagnosis of non-small-cell lung cancer
  • Reported weight stability or loss after cancer diagnosis
  • Body mass index less than or equal to 35 kilograms per meter squared
  • Ability to provide written informed consent
  • Willing and able to comply with all scheduled visits, treatment plans, lab tests, and other study procedure
  • Allow the collection and storage of biospecimens and data for future use

You may not qualify if:

  • Prior diagnosis of diabetes mellitus (type 1 or type 2)
  • Currently pregnant or breastfeeding
  • Contraindication to consuming the liquid mixed meal
  • Any medications affecting gastric motility
  • Any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cancer Metabolism Program

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 10, 2023

Study Start

July 18, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)