NCT07185308尚未招募不适用
Postbiotics Ameliorate Cancer Cachexia in Patients With Non-small-cell Lung Cancer: a Multicentre, Double-blind, Randomised Controlled Trial
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Body-weight change
研究概览
简要总结
This study aims to evaluate the efficacy of the oral postbiotic preparation JK-5G in improving body weight among patients with non-small-cell lung cancer (NSCLC)-related cachexia. By means of a randomized controlled trial, we will compare the between-group difference in body-weight changes between the JK-5G and placebo arms to clarify its nutritional therapeutic benefit.
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
- •Age ≥ 18 years, regardless of gender.
- •Patients with histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) classified as stage III-IV according to the 9th TNM edition of IASLC, who are either currently receiving or have completed chemotherapy combined with immunotherapy.
- •Cachexia was diagnosed according to the international consensus criteria: involuntary weight loss >5 % within 6 months preceding screening, or BMI <20 kg/m² combined with >2 % involuntary weight loss within the same period.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 and an estimated life expectancy of ≥ 4 months.
- •Prior to the first dose of study treatment, adequate organ function must be documented (no blood products, granulocyte-colony-stimulating factors, or thrombopoietic agents within 14 days before randomisation): 1) Absolute neutrophil count ≥ 1.5 × 10^9/L;2)Platelet count ≥ 100 × 10^9/L; 3) Haemoglobin > 90 g/L; 4) Serum creatinine < 1.5 × upper limit of normal (ULN) or creatinine clearance (Cockcroft-Gault) > 50 mL/min; 5) Total bilirubin < 1.5 × ULN (< 3 × ULN in Gilbert's syndrome) ;6) AST and ALT < 2.5 × ULN (≤ 5 × ULN if hepatic metastases present); 7) INR and aPTT ≤ 1.5 × ULN unless the participant is on therapeutic anticoagulation; 8) Left-ventricular ejection fraction (LVEF) > 50 %
- •Participants must be capable of providing written informed consent and comprehending the potential risks associated with the intervention.
- •Participants must demonstrate high adherence to the study protocol.
- •Gastrointestinal function score of < 5.
排除标准
- •Current presence of reversible causes of reduced food intake (e.g., oral mucositis or mechanical obstruction).
- •Participants who are receiving tube feeding or parenteral nutrition at the time of screening or randomization.
- •Cachexia attributable to other etiologies (e.g., chronic obstructive pulmonary disease, heart failure, or HIV/AIDS).
- •Major surgery within 4 weeks prior to randomization or major surgery planned during the study period.
- •Initiation of systemic corticosteroid therapy within 4 weeks prior to randomization.
- •Use of any appetite- or weight-enhancing agent within 30 days before randomisation, including anamorelin, megestrol acetate, cannabinoids, olanzapine, or mirtazapine.
- •Use of antibiotics or probiotic-containing medications/foods within 2 weeks prior to randomization.
- •Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight reduction within 30 days prior to randomization.
- •Pregnant or lactating women.
- •Participants who are unable to understand the study objectives or who do not agree to comply with the study requirements.
- •Individuals who lack full legal capacity or whose legal capacity is restricted.
- •Any medical condition that could interfere with the interpretation of study results or increase the participant's risk in the opinion of the investigators.
- •Participation in any other clinical trial.
- •Gastrointestinal function score of ≥ 5.
结局指标
主要结局
Body-weight change
时间窗: From enrollment to the end of treatment at 12 weeks
The primary endpoint of this study is the between-group difference in change from baseline to week 12 in body weight between the postbiotics arm and the placebo arm.
次要结局
- FAACT-ACS score(From enrollment to the end of treatment at 12 weeks)
- Immuno-inflammatory biomarker changes(From enrollment to the end of treatment at 12 weeks)
- Lumbar skeletal muscle index (LSMI) assessed by computed tomography(From enrollment to the end of treatment at 12 weeks)
- Objective response rate(From enrollment to the end of treatment at 12 weeks)
- Circulating growth-differentiation factor-15 (GDF-15) levels(From enrollment to the end of treatment at 12 weeks)
- Incidence of adverse events(From enrollment to the end of treatment at 12 weeks)
- FAACT-ACS score(From enrollment to the end of treatment at 12 weeks)
- Immuno-inflammatory biomarker changes(From enrollment to the end of treatment at 12 weeks)
- MDASI score(From enrollment to the end of treatment at 12 weeks)
- The EORTC Quality-of-Life Questionnaire Core(From enrollment to the end of treatment at 12 weeks)
- Lumbar skeletal muscle index (LSMI) assessed by computed tomography(From enrollment to the end of treatment at 12 weeks)
研究者
Hongxia Xu
Director of the Department of Clinical Nutrition
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
研究点 (2)
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