Frailty Syndrome, Gastrointestinal Cancer, Nutritional Deficiency
Conditions
Keywords
silkworm pupa tablets, gastrointestinal malignancies, nutritional risk, frailty
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSilkworm pupa tablets
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.
DIETARY_SUPPLEMENTControl product
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.
Sponsors
Xiaosun Liu, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Voluntarily participate in the clinical study, fully understand the study and sign the informed consent form (ICF); willing and able to follow and complete all trial procedures. * Gender unrestricted, age at the time of signing ICF: ≥18 years, ≤80 years. * Diagnosed with a malignant gastrointestinal tumor, 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. * At the time of screening, a nutritional risk score of ≥3 (based on the NRS 2002 nutritional risk screening tool) . * In good general condition, with an ECOG performance status score of ≤2. * Agree to provide peripheral blood, stool, and urine samples for biomarker analysis during the study period.
Exclusion criteria
* At the time of screening, presence of tumor recurrence or metastasis. * At the time of screening, presence of another active malignancy requiring concurrent treatment. * Expected survival of ≤3 months. * Unable to take oral nutrition, requiring enteral feeding tubes, or having malabsorption syndrome or any condition affecting gastrointestinal absorption; e.g., chronic diarrhea (watery stools; defecation frequency ≥5 times a day). * Patients who are planning a pregnancy, are pregnant, or are breastfeeding. * Allergic to any known components of the trial materials. * Presence of serious primary diseases of the heart, brain, lungs, liver, kidneys, endocrine, hematological, neurological, or other systems, or other acute or chronic diseases that could significantly affect treatment and prognosis. * Presence of other severe physical or mental illnesses or laboratory abnormalities that may increase the risk associated with participation in the study, or patients deemed unsuitable for participation by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 3 months | Measured at baseline and 1 month, 2 months, 3 months after enrollment |
| Frailty prevalence | 3 months | The incidence of frailty, using Fried frailty phenotype to assess physical frailty, measured at baseline and 1 month, 2 months, 3 months after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (BMI) | 3 months | Calculated as weight (kg)/height (m2), measured at baseline and 1 month, 2 months, 3 months after enrollment |
| L3-SMI | 3 months | 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 |
| Sarcopenia prevalence | 3 months | 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 |
| Quality of life | 3 months | Using the questionnaire of EORTC QLQ-C30 measured at baseline and 1 month, 2 months, 3 months after enrollment |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiaosun Liu
First Affiliated Hospital of Zhejiang University
Outcome results
None listed