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

NCT07185308 | Not Yet Recruiting

• 1 other identifier: DP-2025-239
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Non-small-cell lung cancer; Cachexixa; Postbiotics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Objective response rate

  From enrollment to the end of treatment at 12 weeks

• FAACT-ACS score

  From enrollment to the end of treatment at 12 weeks

• MDASI score

  From enrollment to the end of treatment at 12 weeks

• Immuno-inflammatory biomarker changes

  From enrollment to the end of treatment at 12 weeks

• The EORTC Quality-of-Life Questionnaire Core

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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.

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.

Dietary Supplement: Postbiotics, 2.5 g per dose, three times per day

Interventions

Postbiotics, 2.5 g per dose, three times per day 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).

JK-5G postbiotics group

Placebo, 2.5 g per dose, three times per day 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).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %
• 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.

You may not qualify if:

• 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.
• Pregnant or lactating women.
• Participants who are unable to understand the study objectives or who do not agree to comply with the study requirements.
• 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.
• Participation in any other clinical trial.
• Gastrointestinal function score of ≥ 5.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• The First Hospital of Jilin University: collaborator
• Fujian Cancer Hospital: collaborator
• Zhongnan Hospital: collaborator
• National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College: collaborator
• Affiliated Hospital of Jiangnan University: collaborator
• Jiangsu Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Henan University: collaborator
• Shanghai Changzheng Hospital: collaborator
• Zhengzhou University: collaborator

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Cachexia; Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hongxia Xu

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

  STUDY DIRECTOR

Central Study Contacts

Hongxia Xu, PhD, MD

CONTACT

+86 23 68729640; hx_xu2015@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Clinical Nutrition

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 22, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)