This is a multicenter, double-blind randomized controlled clinical study designed to evaluate the efficacy and safety of oral nutritional supplements (ONS) containing levocarnitine for cachexia in lung cancer patients scheduled for or undergoing chemotherapy.
Study Design:
Recruitment: Approximately 126 pathologically confirmed patients meeting the inclusion criteria will be enrolled across four hospitals (Army Characteristic Medical Center, Chongqing Fifth People's Hospital, Chongqing Thirteenth People's Hospital, and Chongqing Qianjiang District Central Hospital). The planned enrollment is 60 patients at Army Characteristic Medical Center, 22 at Chongqing Fifth People's Hospital, 22 at Chongqing Thirteenth People's Hospital, and 22 at Chongqing Qianjiang District Central Hospital.
Randomization: Patients will be randomly assigned in a 1:1 ratio to the control group (63 patients) or the intervention group (63 patients).
Interventions:
Control Group: Receive 500 mL of enteral nutrition solution daily for 12 weeks (84 days).
Intervention Group: Receive 500 mL of enteral nutrition solution containing 4 g of levocarnitine daily for 12 weeks (84 days).
Evaluations:
Efficacy Assessments: Body composition analysis and other evaluations will be conducted at baseline and after ONS treatment with levocarnitine to assess the effectiveness of the intervention.
Safety Assessments: Safety events during the levocarnitine-containing ONS treatment period and within 28 days after neoadjuvant therapy will be collected to evaluate treatment safety.
Follow-up: After chemotherapy, the investigator will determine the optimal adjuvant treatment and follow-up protocols to assess recurrence and survival outcomes.
Weight loss >5% in the past 6 months (without active weight loss);
Body mass index (BMI) <20 and weight loss >2%;
Absolute neutrophil count ≥1.5×10⁹/L;
Platelet count ≥100×10⁹/L;
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);
Patients with clinically significant arrhythmia who have been stable for >14 days before the first drug administration may be enrolled;
Parallel
L-Carnitine 4g
Dietary supplement500ml enteral nutrition solution containing 4g of L-carnitine
Enteral Nutrition
Dietary supplementEnteral nutrition was given 500 ml per day for a total of 84 days.
Total Skeletal Muscle Mass
The total skeletal muscle mass (TSMM) is the primary endpoint of this study. It is defined as the total weight of skeletal muscles throughout the human body, typically expressed in kilograms (kg). This assessment is conducted using a body composition analyzer.
BMI
The body mass index (BMI) is defined as a value obtained by dividing body weight (in kilograms) by the square of height (in meters). The formula is: weight / height²
Grip strength
It is defined as the force generated by the contraction of hand muscles. This force reflects the comprehensive strength level of hand flexor muscles (such as the flexor digitorum superficialis, flexor digitorum profundus, and flexor pollicis longus) and related muscle groups (such as the thenar muscles and hypothenar muscles). To some extent, it can reflect an individual's overall muscle strength and physical function status. This assessment is measured using an electronic grip dynamometer.
Inflammatory cytokines
Inflammatory molecules refer to a class of bioactive substances produced and released during the inflammatory response, which play a key role in the initiation, development, and regulation of inflammation. This assessment uses interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP).
Nutritional Score
The nutritional score is defined as a quantitative method used to assess the nutritional status of individuals or groups, and this assessment is measured using PG-SGA and NRS2002.
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