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

Launched by DAPING HOSPITAL AND THE RESEARCH INSTITUTE OF SURGERY OF THE THIRD MILITARY MEDICAL UNIVERSITY · Jun 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a special nutritional drink containing a substance called levocarnitine can help improve a condition called cachexia in patients with non-small cell lung cancer. Cachexia is a syndrome where people lose weight and muscle, which can make it harder to fight cancer and tolerate treatments like chemotherapy. The study will compare patients who receive the nutritional drink with levocarnitine to those who receive a similar drink without it, to see if the levocarnitine helps maintain or improve body strength and overall health during cancer treatment.

Patients who might be eligible are adults with confirmed non-small cell lung cancer who are experiencing weight loss or muscle loss related to cachexia and are either about to start or already undergoing chemotherapy. They need to be generally healthy enough to take part, with no major heart, digestive, or other serious conditions that could interfere with the study. Participants will be randomly assigned to one of two groups and will drink 500 mL of the nutritional supplement every day for 12 weeks. During and after this period, doctors will check their body composition and monitor for any side effects. After chemotherapy, the medical team will decide the best follow-up care. This study is important because managing cachexia may help improve quality of life and treatment outcomes for lung cancer patients.

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Eligibility criteria

• Inclusion Criteria:
• * 1. Primary lung tumor confirmed by cytology or histology; 2.Meeting the diagnostic criteria for cachexia (with one of the following criteria):
• • 1. Weight loss \>5% in the past 6 months (without active weight loss);
• • 2. Body mass index (BMI) \<20 and weight loss \>2%;
• 3. Decreased total skeletal muscle index (detected by bioelectrical impedance analysis: \<7.26 kg/m² for males; \<5.45 kg/m² for females) and weight loss \>2%; 3.Age ≥18 years; 4.Patients scheduled to receive or currently undergoing chemotherapy; 5.Patients with an expected survival period ≥3 months; 6.Signed written informed consent and able to comply with the study visit schedule and relevant procedures; 7.Sufficient organ function before the first study treatment (no use of any blood components, leukocyte-elevating drugs, or platelet-elevating drugs within 14 days prior to randomization):
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• • 1. Absolute neutrophil count ≥1.5×10⁹/L;
• • 2. Platelet count ≥100×10⁹/L;
• • 3. Hemoglobin \>90 g/L;
• • 4. Serum creatinine \<1.5×upper limit of normal (ULN) or creatinine clearance (CLcr) calculated by the Cockcroft-Gault formula \>50 mL/min;
• • 5. Total bilirubin \<1.5×ULN (for Gilbert syndrome patients, \<3×ULN is acceptable);
• • 6. AST and ALT \<2.5×ULN (for patients with liver metastases, ≤5×ULN);
• • 7. International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN, unless the subject is receiving anticoagulant therapy
• Exclusion Criteria:
• * 1.Patients scheduled for lung cancer surgery within the next 3 months; 2.Patients with uncontrolled hyperglycemia after adequate treatment; 3.Patients allergic to levocarnitine; 4.Patients with contraindications to enteral nutrition, including but not limited to active gastrointestinal bleeding, complete intestinal obstruction, etc.; 5.Patients with diseases severely affecting digestion and absorption, including but not limited to subtotal gastrectomy, history of intestinal surgery, etc.; 6.Patients with clinically significant cardiovascular and cerebrovascular diseases, including but not limited to:
• • 1. Myocardial infarction or unstable angina within 6 months before the first drug administration;
• • 2. Stroke or transient ischemic attack within 6 months before the first drug administration;
• • 3. Hypertension that cannot be controlled after optimal antihypertensive treatment (systolic blood pressure \>160 mmHg and/or diastolic blood pressure ≥100 mmHg);
• • 4. Patients with clinically significant arrhythmia who have been stable for \>14 days before the first drug administration may be enrolled;
• • 5. Congestive heart failure (New York Heart Association \[NYHA\] functional classification \> Class 3; see Appendix VI for details);
• • 6. Myocarditis; 7.Patients currently participating in interventional clinical research treatment, or who have received other investigational drugs or devices within 4 weeks prior to randomization; 8.Active tuberculosis or tuberculosis requiring medical intervention at the current stage, including but not limited to pulmonary tuberculosis; 9.Patients with known mental illnesses or substance abuse that may affect compliance with trial requirements, or a history of alcohol abuse; 10.Patients with medical history, diseases, treatments, or laboratory abnormalities that may interfere with trial results or prevent the subject from participating in the study throughout the process, or where the investigator deems participation not in the subject's best interest; 11.Local or systemic diseases caused by non-malignant tumors, or secondary reactions to cancer, which may lead to higher medical risks and/or uncertainty in survival evaluation.