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

NCT06551675 | Completed

• 1 other identifier: IIT20240064C
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Nutritional Deficiency; Gastrointestinal Cancer; Frailty Syndrome

Keywords

silkworm pupa tablets; gastrointestinal malignancies; nutritional risk; frailty

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Body mass index (BMI)

  3 months

• L3-SMI

  3 months

• Sarcopenia prevalence

  3 months

• Quality of life

  3 months

• Quality of life

  3 months

Study Arms (2)

Silkworm pupa tablets group

EXPERIMENTAL

Wanshililongbao silkworm pupa tablets.

Dietary Supplement: Silkworm pupa tablets

Control group

SHAM COMPARATOR

Contains 0.5% of the active ingredient of the study product, indistinguishable in appearance.

Dietary Supplement: Control product

Interventions

Silkworm pupa tablets DIETARY_SUPPLEMENT

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.

Silkworm pupa tablets group

Control product DIETARY_SUPPLEMENT

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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaosun Liu, MD: lead

Study Sites (4)

Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

Hangzhou, Zhejiang, 310000, China

Location

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

The Second Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Hangzhou Institute of Medicine Chinese Academy of Sciences

Hangzhou, China

Location

MeSH Terms

Conditions

Malnutrition; Gastrointestinal Neoplasms; Frailty

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xiaosun Liu

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director of gastrointestinal surgery department

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 13, 2024
• Study Start: August 14, 2024
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)