Postbiotics Ameliorate Cachexia in Patients With Non-small-cell Lung Cancer

NCT ID: NCT07185308

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-12-31

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.

Conditions

Cachexia; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control 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.

Group Type: PLACEBO_COMPARATOR

Placebo, 2.5 g per dose, three times per day

Intervention Type: DIETARY_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).

JK-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.

Group Type: EXPERIMENTAL

Postbiotics, 2.5 g per dose, three times per day

Intervention Type: DIETARY_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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years, regardless of gender.

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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.

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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.

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4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 and an estimated life expectancy of ≥ 4 months.

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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 %

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6. Participants must be capable of providing written informed consent and comprehending the potential risks associated with the intervention.

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7. Participants must demonstrate high adherence to the study protocol.

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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).

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2. Participants who are receiving tube feeding or parenteral nutrition at the time of screening or randomization.

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3. Cachexia attributable to other etiologies (e.g., chronic obstructive pulmonary disease, heart failure, or HIV/AIDS).

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4. Major surgery within 4 weeks prior to randomization or major surgery planned during the study period.

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5. Initiation of systemic corticosteroid therapy within 4 weeks prior to randomization.

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6. 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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7. Use of antibiotics or probiotic-containing medications/foods within 2 weeks prior to randomization.

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8. Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight reduction within 30 days prior to randomization.

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9. Pregnant or lactating women.

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10. Participants who are unable to understand the study objectives or who do not agree to comply with the study requirements.

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11. Individuals who lack full legal capacity or whose legal capacity is restricted.

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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.

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13. Participation in any other clinical trial.

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14. Gastrointestinal function score of ≥ 5.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Zhongnan Hospital

OTHER

Sponsor Role: collaborator

National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

UNKNOWN

Sponsor Role: collaborator

Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role: collaborator

Jiangsu Provincial People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Henan University

UNKNOWN

Sponsor Role: collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role: collaborator

Zhengzhou University

OTHER

Sponsor Role: collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hongxia Xu

Director of the Department of Clinical Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongxia Xu

Role: STUDY_DIRECTOR

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Locations

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Central Contacts

Hongxia Xu, PhD, MD

Role: CONTACT

hx_xu2015@163.com

+86 23 68729640

Facility Contacts

Hongxia Xu, PhD, MD

Role: primary

hx_xu2015@163.com

+86 23 68729640

Other Identifiers

DP-2025-239

Identifier Type: -

Identifier Source: org_study_id