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Enteral Nutrition With L-Carnitine for Cachexia in Non-Small Cell Lung Cancer

Plain-language guide to NCT07035444: not phased randomized trial of L-Carnitine, 126 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07035444
Phase
not phased
Status
not yet recruiting
Start
2025-06-30
Completion (planned or actual)
2026-06-30
Participants
126 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Non-Small Cell Lung Cancer; Cachexia
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around L-Carnitine.

It had two arms (groups): Enteral nutrition (active comparator) and Enteral Nutrition with L-Carnitine (experimental).

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 126 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 1\. Primary lung tumor confirmed by cytology or histology; 2.Meeting the diagnostic criteria for cachexia (with one of the following criteria):. Absolute neutrophil count ≥1.5×10⁹/L;. Platelet count ≥100×10⁹/L;. Total bilirubin \<1.5×ULN (for Gilbert syndrome patients, \<3×ULN is acceptable);. AST and ALT \<2.5×ULN (for patients with liver metastases, ≤5×ULN);.

The full record lists 11 inclusion and 7 exclusion criteria; among the exclusions: myocardial infarction or unstable angina within 6 months before the first drug administration;; stroke or transient ischemic attack within 6 months before the first drug administration;; hypertension that cannot be controlled after optimal antihypertensive treatment (systolic blood pressure \>160 mmhg and/or diastolic blood pressure ≥100 mmhg);.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2025-06-30 with completion listed for 2026-06-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Total Skeletal Muscle Mass (time frame: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months).

It also tracked 5 secondary outcomes, for example BMI, Grip strength, Inflammatory cytokines, Nutritional Score and Quality of Life Score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 126 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.

Our Notes on the Compound

L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.