A Randomized, Double-blind, Placebo-controlled, Prospective, Multi-center Trial Evaluating the Improvement of Nutritional Status and Sarcopenia With Silkworm Pupa Tablets in Patients With Malignancies

NCT07554807 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Zhejiang University

Phase

Phase 3

Started

2026-04-01

Last updated

2026-04-28

Condition(s) studied

Nutritional DeficiencyGastrointestinal CancersSarcopenia

Investigational drug(s) / intervention(s)

Silkworm pupa tabletsPlacebo

Silkworm pupa tablets: For Experimental arm: Dietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals

Placebo: Control arm: Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals.

Study summary

This is a randomized, double-blind, placebo-controlled, parallel-group, prospective, multi-center clinical trial, to evaluate the efficacy of silkworm pupa tablets in improving nutritional status and sarcopenia in patients with malignancies who have completed comprehensive treatment. All participants will be randomly assigned (1:1) to either experimental group (n=240): dietary advice + Wanshili Longbao Silkworm Pupa Tablets (main ingredients: freeze-dried active mulberry cocoon pupa powder, maltitol, milk mineral salt, mannitol, maltodextrin), 2 tablets three times daily before meals for 3 months, or control group (n=240): dietary advice + placebo (identical appearance), 2 tablets three times daily before meals for 3 months. The primary endpoint is sarcopenia prevalence at 3 months (based on AWGS 2019 criteria: muscle strength, muscle mass, and physical function).

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. fully understand and sign the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures 2. Any gender, age at ICF signing: ≥ 18 years, ≤ 80 years 3. Confirmed diagnosis of malignancy 4. At screening/ enrollment, meet the definition of sarcopenia according to the 2019 Asian Working Group for Sarcopenia 5. Generally good condition, ECOG performance status ≤ 2 6. Agree to provide peripheral blood, stool, and urine samples for biomarker analysis during the study Exclusion Criteria: 1. Presence of gastrointestinal obstruction preventing oral intake at screening/enrollment 2. Use of immunosuppressants at screening/enrollment 3. Life expectancy ≤ 3 months 4. Presence of malabsorption syndrome or any condition affecting gastrointestinal absorption, e.g., chronic diarrhea (watery stools; daily stool frequency ≥ 5 times) 5. Patients planning pregnancy, pregnant, or breastfeeding 6. Known allergy to any component of the investigational products 7. Presence of severe primary diseases of the heart, brain, lung, liver, kidney, endocrine, blood, nervous systems or other acute/chronic diseases that could significantly affect treatment and prognosis 8. Presence of other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or patients deemed unsuitable for the study by the investigator

Primary outcome measure(s)

Sarcopenia prevalence — 3 months
Participants completed all comprehensive treatment, who met the 2019 Asian Working Group for Sarcopenia (AWGS) diagnostic criteria. Sarcopenia was evaluated at baseline and 1 month, 2 months, 3 months after enrollment

Trial sites (4)

Facility	City	Region
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University	Hangzhou	Zhejiang
The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang
The Second Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang
Hangzhou Institute of Medicine Chinese Academy of Sciences	Hangzhou	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07554807 on ClinicalTrials.gov ↗ ← All trials in China