Cachexia, Non-Small Cell Lung Cancer
Conditions
Keywords
L-carnitine, Enteral nutrition
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTL-Carnitine 4g
500ml enteral nutrition solution containing 4g of L-carnitine
DIETARY_SUPPLEMENTEnteral Nutrition
Enteral nutrition was given 500 ml per day for a total of 84 days.
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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): <!-- --> 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Skeletal Muscle Mass | At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months | 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 | At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months | 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 | At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months | 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 | At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months | 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. |
| Quality of Life Score | At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months | The quality of life score is a quantitative evaluation of the quality of life of individuals or groups, and this assessment is conducted using the EORTC QLQ-C30 C3.0 Chinese version (Quality of Life Questionnaire for Lung Cancer Patients). |
Countries
China
Contacts
Primary Contactshiqiao CHEN
Backup ContactHongxia xu
Outcome results
None listed