Enteral Nutrition Supplemented With L-Carnitine for Cachexia in Non-Small Cell Lung Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Total Skeletal Muscle Mass
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary lung tumor confirmed by cytology or histology; 2.Meeting the diagnostic criteria for cachexia (with one of the following criteria):
- •Weight loss >5% in the past 6 months (without active weight loss);
- •Body mass index (BMI) <20 and weight loss >2%;
- •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):
- •Absolute neutrophil count ≥1.5×10⁹/L;
- •Platelet count ≥100×10⁹/L;
- •Hemoglobin >90 g/L;
- •Serum creatinine <1.5×upper limit of normal (ULN) or creatinine clearance (CLcr) calculated by the Cockcroft-Gault formula >50 mL/min;
- •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);
- •International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN, unless the subject is receiving anticoagulant therapy
排除标准
- •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:
- •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;
- •Congestive heart failure (New York Heart Association [NYHA] functional classification > Class 3; see Appendix VI for details);
- •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.
结局指标
主要结局
Total Skeletal Muscle Mass
时间窗: 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.
次要结局
- BMI(At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months)
- Grip strength(At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months)
- Inflammatory cytokines(At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months)
- Nutritional Score(At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months)
- Quality of Life Score(At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months)