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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
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 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).
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, China
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: From enrollment to the end of treatment at 12 weeks
Objective response rate
The week-12 objective response rate evaluated by CT imaging based on RECIST 1.1 criteria
Time frame: 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).
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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
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Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 weeks