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

ConditionCachexia; Cancer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

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

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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).
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).

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Control groupPlacebo comparator 1 intervention

Group B: JK-5G postbiotics groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame