Cachexia; CancerNCT07185308
Postbiotics Ameliorate Cachexia in Patients With Non-small-cell Lung Cancer
A study testing Postbiotics, 2.5 g per dose, three times per day in people with Cachexia; Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia; Cancer
- What is being tested?
- Postbiotics, 2.5 g per dose, three times per day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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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.
- -
- 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.
- -
- 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.
- -
- Gastrointestinal function score of ≥ 5.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Hongxia Xu, PhD, MD, +86 23 68729640, hx_xu2015@163.com
About this study
Official title: Postbiotics Ameliorate Cancer Cachexia in Patients With Non-small-cell Lung Cancer: a Multicentre, Double-blind, Randomised Controlled Trial
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.
- Conditions
- Cachexia; Cancer
- Being tested
- Postbiotics, 2.5 g per dose, three times per day, Placebo, 2.5 g per dose, three times per day
- Keywords
- Non-small-cell lung cancer, Cachexixa, Postbiotics
- Medical subject headings
- Cachexia, Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postbiotics, 2.5 g per dose, three times per dayDietary supplement
Postbiotics oral powder, 2.5 g per dose, administered three times daily for a total duration of 90 days (four 21-day chemotherapy cycles).
Placebo, 2.5 g per dose, three times per dayDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 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. Receives: Dietary Supplement: Placebo, 2.5 g per dose, three times per day |
| JK-5G postbiotics group | Experimental | 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. Receives: Dietary Supplement: Postbiotics, 2.5 g per dose, three times per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (8)
Objective response rate
The week-12 objective response rate evaluated by CT imaging based on RECIST 1.1 criteria
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cachexia; CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, The First Hospital of Jilin University, Fujian Cancer Hospital, Zhongnan Hospital, National Cancer Center, China, Affiliated Hospital of Jiangnan University, Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Shanghai Changzheng Hospital, Zhengzhou University
- Responsible party
- Principal investigator, Hongxia Xu, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Hongxia Xu, Study director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185308
- Sponsor's protocol ID
- DP-2025-239
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study results will be made publicly available in the form of academic publications.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postbiotics Ameliorate Cancer Cachexia in Patients With Non-small-cell Lung Cancer: a Multicentre, Double-blind, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07185308
- Acronym / sponsor ID
- DP-2025-239
- Conditions
- Cachexia; Cancer
- Keywords
- Non-small-cell lung cancer, Cachexixa, Postbiotics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, The First Hospital of Jilin University, Fujian Cancer Hospital, Zhongnan Hospital, National Cancer Center, China, Affiliated Hospital of Jiangnan University, Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Shanghai Changzheng Hospital, Zhengzhou University
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: Placebo, 2.5 g per dose, three times per dayPlacebo + 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. |
| JK-5G postbiotics group | Experimental | Dietary Supplement: Postbiotics, 2.5 g per dose, three times per dayJK-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postbiotics, 2.5 g per dose, three times per dayPostbiotics oral powder, 2.5 g per dose, administered three times daily for a total duration of 90 days (four 21-day chemotherapy cycles). | Dietary supplement | JK-5G postbiotics group |
| Placebo, 2.5 g per dose, three times per dayPlacebo 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). | Dietary supplement | Control group |
Primary outcome
Body-weight change
Time frame: 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.
8 secondary outcomes
Objective response rate
Time frame: From enrollment to the end of treatment at 12 weeks
FAACT-ACS score
Time frame: From enrollment to the end of treatment at 12 weeks
MDASI score
Time frame: From enrollment to the end of treatment at 12 weeks
Immuno-inflammatory biomarker changes
Time frame: From enrollment to the end of treatment at 12 weeks
The EORTC Quality-of-Life Questionnaire Core
Time frame: From enrollment to the end of treatment at 12 weeks
Circulating growth-differentiation factor-15 (GDF-15) levels
Time frame: From enrollment to the end of treatment at 12 weeks
Incidence of adverse events
Time frame: From enrollment to the end of treatment at 12 weeks
Lumbar skeletal muscle index (LSMI) assessed by computed tomography
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No. The study results will be made publicly available in the form of academic publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongxia Xu study director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postbiotics, 2.5 g per dose, three times per day in people with Cachexia; Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongxia Xu, PhD, MD (+86 23 68729640, hx_xu2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body-weight change (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.