Sarcopenia is common in lung cancer patients. It is one of the significant factors affecting the overall survival, radiotherapy and chemotherapy efficacy, and quality of life of patients with lung cancer. Previous studies have shown that increased protein intake can stimulate postprandial muscle synthesis, and improve muscle mass, strength, function, and overall survival. However, most previous studies have focused on the intervention of whey protein, while the protective effect of soybean protein on lung cancer-related sarcopenia (LCRS) has not yet been fully explored and reached an agreement. So, this study aims to explore the effects of soy and whey protein on muscle, gut microbiota, and clinical outcomes among patients with lung cancer-related sarcopenia, to provide a reference for further nutrition treatment.
This study will last 6 months. For the duration of the study, an anticipated total of 90 participants will be randomly assigned to receive either a 30-gram protein supplement or a placebo daily. There will be a total of 5 study visits, and dietary records, questionnaires, blood and stool collection, and functional testing will occur at all study visits. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
The intervention is made up of soy protein supplements (30g/d) and dietary pattern modification.
The intervention is made up of whey protein supplements (30g/d) and dietary pattern modification.
The intervention is made up of maltodextrin (30g/d) and dietary pattern modification.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Change from Baseline Appendicular skeletal muscle mass index at 3 months
Defined as muscle mass (Unit: kg/m2)
Time frame: 3 months
Change from Baseline Hand grip at 3 months
Defined as muscle strength (Unit: kg)
Time frame: 3 months
Change from Baseline physical performance Baseline at 3 months
Measured by Short Physical Performance Battery (0-12) with higher scores meaning better physical performance.
Time frame: 3 months
Change from Baseline Physical function at 3 months
Measured by FRAIL scale (0-5) with higher scores meaning better physical function.
Time frame: 3 months
Change from Baseline Quality of life questionnaire at 3 months
Measured by EuroQol- 5 Dimension scale (0-5) with higher scores meaning better Quality of life.
Time frame: 3 months
Change from Baseline gut microbiota composition at 3 months
The stool samples of participants before and after intervention were collected and analized by 16S rRNA.
Time frame: 3 months
Number of patients with good Chemotherapy Tolerance
Completing initially planned chemotherapy course is defined as good tolerance; dose adjustment, delayed completion or interruption of treatment are considered as poor tolerance.
Time frame: 3 months
Incidence of Chemotherapy toxicity
Measured after initiation of chemotherapy using the WHO Toxicity Grades (gradeI-IV) with higher grades neaning severer chemotheraphy toxicity.
Time frame: 3 months
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