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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 %
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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.