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;