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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Nutritional Deficiency, Gastrointestinal Cancers, Sarcopenia

In brief

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).

Key facts

Study ID

NCT07554807

Run by

First Affiliated Hospital of Zhejiang University

People needed

480

Starts

2026-04-01

Expected to finish

2028-03-31

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• fully understand and sign the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures
• Any gender, age at ICF signing: ≥ 18 years, ≤ 80 years
• Confirmed diagnosis of malignancy
• At screening/ enrollment, meet the definition of sarcopenia according to the 2019 Asian Working Group for Sarcopenia
• Generally good condition, ECOG performance status ≤ 2
• Agree to provide peripheral blood, stool, and urine samples for biomarker analysis during the study

You may not qualify if…

• Presence of gastrointestinal obstruction preventing oral intake at screening/enrollment
• Use of immunosuppressants at screening/enrollment
• Life expectancy ≤ 3 months
• Presence of malabsorption syndrome or any condition affecting gastrointestinal absorption, e.g., chronic diarrhea (watery stools; daily stool frequency ≥ 5 times)
• Patients planning pregnancy, pregnant, or breastfeeding
• Known allergy to any component of the investigational products
• 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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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