Nutritional risk and malnutrition is common in cancer patients, which is one of the significant factors affecting the overall survival, toxicity during anticancer treatment, and quality of life among patients with cancer. Previous studies have shown that the increased protein intake can stimulate muscle synthesis, and improve muscle mass, strength, function, overall survival, and quality of life. The current study is going to investigate the effectiveness and safety of protein supplements on patients with cancer, in order to provide a reference for further nutrition treatment.
An anticipated total of 100 participants will randomly assigned to receive either a 20-gram protein supplement per day or nutrition counseling to increase the protein intake. there will be a total of 3 study visits, and dietary assessment and blood sample collection will occur at every study visit. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be used in statistical analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
20 gram protein supplement per day
nutrition counseling for guidance of food intake
blood toxicity
blood toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 6 month
nutritional risk
nutritional risk based on nutrition risk screening-2002 (NRS-2002)
Time frame: 6 months
malnutrition
malnutrition assessment based on Global Leadership Initiative on Malnutrition (GLIM)
Time frame: 6 months
phase angle (PA)
phase angle (PA) assessed by multi-Bioelectric Impedance Analysis (m-BIA)
Time frame: 6 month
weight
weight change during the study
Time frame: 6 month
dose limitation
dose limitation
Time frame: 6 months
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