METRIC: Metabolic Response to Food in Advanced Lung Cancer

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05937074

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Other: Weight loss (%)

Study Design

Study Type:

Observational

Anticipated Enrollment :

12 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Metabolic Response to Food in Advanced Lung Cancer

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Outcome Measures

Primary Outcome Measures

Respiratory quotient [Difference between pre- to post-prandial conditions over four hours]
The respiratory quotient will be measured by indirect calorimetry before and after consumption of a liquid mixed meal

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Age greater than or equal to 18 years
Diagnosis of non-small-cell lung cancer that is locally advanced and inoperable
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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pennington Biomedical Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Justin Brown, Director, Cancer Metabolism Program, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT05937074

Other Study ID Numbers:

PBRC 2023-017

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jul 10, 2023