Status:
NOT_YET_RECRUITING
Postbiotics Ameliorate Cachexia in Patients With Non-small-cell Lung Cancer
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborating Sponsors:
First Affiliated Hospital of Wenzhou Medical University
The First Hospital of Jilin University
Conditions:
Cachexia; Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 random...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, regardless of gender.
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- 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.
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- 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.
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- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 and an estimated life expectancy of ≥ 4 months.
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- 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 %
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- Participants must be capable of providing written informed consent and comprehending the potential risks associated with the intervention.
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- Participants must demonstrate high adherence to the study protocol.
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- Gastrointestinal function score of \< 5.
Exclusion
- Current presence of reversible causes of reduced food intake (e.g., oral mucositis or mechanical obstruction).
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- Participants who are receiving tube feeding or parenteral nutrition at the time of screening or randomization.
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- Cachexia attributable to other etiologies (e.g., chronic obstructive pulmonary disease, heart failure, or HIV/AIDS).
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- Major surgery within 4 weeks prior to randomization or major surgery planned during the study period.
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- Initiation of systemic corticosteroid therapy within 4 weeks prior to randomization.
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- Use of any appetite- or weight-enhancing agent within 30 days before randomisation, including anamorelin, megestrol acetate, cannabinoids, olanzapine, or mirtazapine.
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- Use of antibiotics or probiotic-containing medications/foods within 2 weeks prior to randomization.
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- Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight reduction within 30 days prior to randomization.
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- Pregnant or lactating women.
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- Participants who are unable to understand the study objectives or who do not agree to comply with the study requirements.
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- Individuals who lack full legal capacity or whose legal capacity is restricted.
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- Any medical condition that could interfere with the interpretation of study results or increase the participant's risk in the opinion of the investigators.
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- Participation in any other clinical trial.
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- Gastrointestinal function score of ≥ 5.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07185308
Start Date
November 1 2025
End Date
December 31 2026
Last Update
September 25 2025
Active Locations (1)
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1
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, China, 400042