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.
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.
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.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
Collaborator
The First Hospital of Jilin University
Collaborator
Fujian Cancer Hospital
Collaborator
Zhongnan Hospital
Collaborator
National Cancer Center, China
Collaborator
Affiliated Hospital of Jiangnan University
Collaborator
Jiangsu Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Henan University
Collaborator
Shanghai Changzheng Hospital
Collaborator
Zhengzhou University
Collaborator