Non-small-cell lung cancer (NSCLC) patients with cancer cachexia.
Conditions
Interventions
Control group:Placebo + standard chemotherapy + ICIs (PD-1/PD-L1 inhibitors)
JK-5G postbiotics group:JK-5G + standard chemotherapy + ICIs (PD-1/PD-L1 inhibitors)
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, regardless of gender. 2. 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. 3. Cachexia was diagnosed according to the international consensus criteria: involuntary weight loss >5 % within 6 months preceding screening, or BMI 2 % involuntary weight loss within the same period. 4. Eastern Cooperative Oncology Group (ECOG) performance status = 4 months. 5. 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 50 mL/min; 5) Total bilirubin 50 %; 6. Participants must be capable of providing written informed consent and comprehending the potential risks associated with the intervention. 7. Participants must demonstrate high adherence to the study protocol. 8. Gastrointestinal function score of < 5.
Exclusion criteria
Exclusion criteria: 1. Current presence of reversible causes of reduced food intake (e.g., oral mucositis or mechanical obstruction). 2. Participants who are receiving tube feeding or parenteral nutrition at the time of screening or randomization. 3. Cachexia attributable to other etiologies (e.g., chronic obstructive pulmonary disease, heart failure, or HIV/AIDS). 4. Major surgery within 4 weeks prior to randomization or major surgery planned during the study period. 5. Initiation of systemic corticosteroid therapy within 4 weeks prior to randomization. 6. Use of any appetite- or weight-enhancing agent within 30 days before randomisation, including anamorelin, megestrol acetate, cannabinoids, olanzapine, or mirtazapine. 7. Use of antibiotics or probiotic-containing medications/foods within 2 weeks prior to randomization. 8. Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight reduction within 30 days prior to randomization. 9. Pregnant or lactating women. 10. Participants who are unable to understand the study objectives or who do not agree to comply with the study requirements. 11. Individuals who lack full legal capacity or whose legal capacity is restricted. 12. Any medical condition that could interfere with the interpretation of study results or increase the participant’s risk in the opinion of the investigators. 13. Participation in any other clinical trial. 14. Gastrointestinal function score of >= 5.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional assessment of anorexia/cachexia therapy questionnaire(FAACT);Blood routine and liver/kidney function tests; | — |
Countries
China
Contacts
Public ContactHongxia Xu
Army Medical Center of PLA
Outcome results
None listed