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

Официальное название

Postbiotics Ameliorate Cancer Cachexia in Patients With Non-small-cell Lung Cancer: a Multicentre, Double-blind, Randomised Controlled Trial

Обзор

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.

Вмешательства

• Пищевая добавка 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).
• Пищевая добавка 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).

Первичные конечные точки

• Body-weight change [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (8)

• Objective response rate [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• FAACT-ACS score [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• MDASI score [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Immuno-inflammatory biomarker changes [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• The EORTC Quality-of-Life Questionnaire Core [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Circulating growth-differentiation factor-15 (GDF-15) levels [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Incidence of adverse events [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Lumbar skeletal muscle index (LSMI) assessed by computed tomography [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical Univer — Чунцин

Идентификаторы

NCT: NCT07185308 · DP-2025-239

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗