Effect of Silkworm Pupa Tablets in Gastrointestinal Malignancies at Nutritional Risk Following Radical Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Cancer; Frailty Syndrome; Nutritional Deficiency
• Intervention / Treatment: Dietary supplement: Silkworm pupa tablets; Dietary supplement: Control product

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Hangzhou Institute of Medicine Chinese Academy of Sciences
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, College of Medicine, Zhejiang University
    • Hangzhou, Zhejiang, China, 310000
      • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital, College of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silkworm pupa tablets group; Wanshililongbao silkworm pupa tablets.	Dietary supplement: Silkworm 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.
Sham Comparator: Control group; Contains 0.5% of the active ingredient of the study product, indistinguishable in appearance.	Dietary supplement: Control 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Measured at baseline and 1 month, 2 months, 3 months after enrollment	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI)	Calculated as weight (kg)/height (m2), measured at baseline and 1 month, 2 months, 3 months after enrollment	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	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	3 months
Quality of life	Using the questionnaire of EORTC QLQ-C30 measured at baseline and 1 month, 2 months, 3 months after enrollment	3 months
Quality of life	Using the questionnaire of EORTC QLQ-STO22, measured at baseline and 1 month, 2 months, 3 months after enrollment	3 months

Collaborators and Investigators

• Sponsor: Xiaosun Liu, MD
• Investigators: Principal Investigator: Xiaosun Liu, First affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Actual): October 26, 2025
• Study Completion (Actual): October 26, 2025

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: frailty; gastrointestinal malignancies; nutritional risk; silkworm pupa tablets
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Frailty; Malnutrition; Gastrointestinal Neoplasms; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: IIT20240064C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No