This is a randomized, double-blind, very low dose parallel-controlled, prospective, multi-center trial evaluating the improvement of nutritional status and frailty with silkworm pupa tablets after radical resection of gastrointestinal malignancies for 3 months intervention. The primary endpoints are body weight and frailty prevalence, The secondary endpoints are body mass index (BMI), skeletal muscle index (SMI) at the third lumbar vertebra (L3-SMI), sarcopenia prevalence and quality of life.
Previous study has indicated that silkworms pupae extracts may increase muscle mass and strength, here we conduct a randomized, double-blind, very low dose parallel-controlled, prospective, multi-center trial. 1. Study population: malignant gastrointestinal tumors, including gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer, and has undergone radical surgical resection. If necessary, perioperative systemic treatment has been completed by the time of screening, and has a nutritional risk score of ≥3 (based on the NRS 2002 nutritional risk screening tool). 2. Sample size: totally 120 cases, including 60 cases in the experimental group and 60 cases in the control group. 3. Research content: In this study, participants will begin taking the trial product or control immediately upon enrollment, with a treatment duration of 3 months.Experimental Group: Wanshililongbao silkworm pupa tablets. Control Group: contains 0.5% of the active ingredient of the trial product, indistinguishable in appearance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Participants will begin taking the silkworm pupa tablets immediately upon enrollment, 1200mg/tablet, two tablets a time, twice a day (BID), with a treatment duration of three months.
The sham comparator contains 0.5% of the active ingredient of the study product, indistinguishable in appearance. Participants will begin taking the control immediately upon enrollment, 1200mg/tablet, two tablets a time, twice a day (BID), with a treatment duration of three months.
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Hangzhou Institute of Medicine Chinese Academy of Sciences
Hangzhou, China
Body weight
Measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
Frailty prevalence
The incidence of frailty, using Fried frailty phenotype to assess physical frailty, measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
Body mass index (BMI)
Calculated as weight (kg)/height (m2), measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
L3-SMI
Derived as the ratio of skeletal muscle area (SMA) to height \[SMA (cm2)/height (m2)\], at the third lumbar vertebra, measured at baseline and after 3 months
Time frame: 3 months
Sarcopenia prevalence
The incidence of sarcopenia, using the diagnostic criteria for sarcopenia published by the Asian Sarcopenia Working Group (AWGS) in 2019 or L3-SMI criteria, measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
Quality of life
Using the questionnaire of EORTC QLQ-C30 measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
Quality of life
Using the questionnaire of EORTC QLQ-STO22, measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
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