Trial Radar AI | ||
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Clinical Trial NCT07185308 for Cachexia; Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Postbiotics Ameliorate Cachexia in Patients With Non-small-cell Lung Cancer 150 Randomized
Postbiotics Ameliorate Cancer Cachexia in Patients With Non-small-cell Lung Cancer: a Multicentre, Double-blind, Randomised Controlled Trial
- DP-2025-239
Cachexixa
Postbiotics
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Placebo ComparatorControl group Placebo + standard chemotherapy + ICIs (PD-1/PD-L1 inhibitors. The placebo was administered at the same dose and on the same schedule as the JK-5G group. | Placebo, 2.5 g per dose, three times per day Placebo made of cyclodextrine, oral powder, 2.5 g per dose, administered three times daily for a total duration of 90 days (four 21-day chemotherapy cycles). |
ExperimentalJK-5G postbiotics group JK-5G + standard chemotherapy + ICIs (PD-1/PD-L1 inhibitors). The intervention period for JK-5G spanned 90 days, covering four 21-day chemotherapy cycles, with a dosage of 2.5 g administered three times daily. | Postbiotics, 2.5 g per dose, three times per day Postbiotics oral powder, 2.5 g per dose, administered three times daily for a total duration of 90 days (four 21-day chemotherapy cycles). |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Body-weight change | 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. | From enrollment to the end of treatment at 12 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective response rate | The week-12 objective response rate evaluated by CT imaging based on RECIST 1.1 criteria | From enrollment to the end of treatment at 12 weeks |
FAACT-ACS score | Change from baseline to week 12 in the FAACT subscale scores (FAACT-ACS and FAACT-5IASS). | From enrollment to the end of treatment at 12 weeks |
MDASI score | Changes from baseline to week 12 in the pain, fatigue, nausea, and sleep disturbance items of the M.D. Anderson Symptom Inventory (MDASI) | From enrollment to the end of treatment at 12 weeks |
Immuno-inflammatory biomarker changes | Biomarker changes in CRP、IL-1、IL-6 and TNF-α | From enrollment to the end of treatment at 12 weeks |
The EORTC Quality-of-Life Questionnaire Core | Changes in the EORTC Quality-of-Life Questionnaire Cores scores, a 30-item cancer-specific instrument that yields five functional scales. | From enrollment to the end of treatment at 12 weeks |
Circulating growth-differentiation factor-15 (GDF-15) levels | Changes in circulating growth-differentiation factor-15 (GDF-15) levels | From enrollment to the end of treatment at 12 weeks |
Incidence of adverse events | Incidence of adverse events and occurrence of laboratory abnormalities, vital-sign anomalies, and electrocardiographic deviations. | From enrollment to the end of treatment at 12 weeks |
Lumbar skeletal muscle index (LSMI) assessed by computed tomography | Change from baseline in lumbar skeletal muscle index (LSMI) assessed by computed tomography. | From enrollment to the end of treatment at 12 weeks |
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.
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.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityChongqing Municipality