Postbiotics Ameliorate Cancer Cachexia: a Multicentre, Double-blind, Randomised Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Cachexia; Cancer

• Registration Number: NCT07185308
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Study Start: 2025-11-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 <20 kg/m² combined with >2 % involuntary weight loss within the same period.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 and an estimated life expectancy of ≥ 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 < 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 %
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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body-weight change	From enrollment to the end of treatment at 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Objective response rate	From enrollment to the end of treatment at 12 weeks	The week-12 objective response rate evaluated by CT imaging based on RECIST 1.1 criteria
FAACT-ACS score	From enrollment to the end of treatment at 12 weeks	Change from baseline to week 12 in the FAACT subscale scores (FAACT-ACS and FAACT-5IASS).
Immuno-inflammatory biomarker changes	From enrollment to the end of treatment at 12 weeks	Biomarker changes in CRP、IL-1、IL-6 and TNF-α
Lumbar skeletal muscle index (LSMI) assessed by computed tomography	From enrollment to the end of treatment at 12 weeks	Change from baseline in lumbar skeletal muscle index (LSMI) assessed by computed tomography.
MDASI score	From enrollment to the end of treatment at 12 weeks	Changes from baseline to week 12 in the pain, fatigue, nausea, and sleep disturbance items of the M.D. Anderson Symptom Inventory (MDASI)
The EORTC Quality-of-Life Questionnaire Core	From enrollment to the end of treatment at 12 weeks	Changes in the EORTC Quality-of-Life Questionnaire Cores scores, a 30-item cancer-specific instrument that yields five functional scales.
Circulating growth-differentiation factor-15 (GDF-15) levels	From enrollment to the end of treatment at 12 weeks	Changes in circulating growth-differentiation factor-15 (GDF-15) levels
Incidence of adverse events	From enrollment to the end of treatment at 12 weeks	Incidence of adverse events and occurrence of laboratory abnormalities, vital-sign anomalies, and electrocardiographic deviations.