Postbiotics Ameliorate Cachexia in Patients With Non-small-cell Lung Cancer (NCT07185308) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Postbiotics Ameliorate Cachexia in Patients With Non-small-cell Lung Cancer
China150 participantsStarted 2025-11-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
What they're measuring
1
Body-weight change
Timeframe: From enrollment to the end of treatment at 12 weeks
Trial details
NCT IDNCT07185308
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
✕. 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.