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 | Not Yet Recruiting Phase 3

• 1 other identifier: IIT20250149C-R1
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Gastrointestinal Cancers; Sarcopenia; Nutritional Deficiency

Keywords

silkworm pupa tablets; gastrointestinal malignancies; nutritional risk

Outcome Measures

Primary Outcomes (1)

• Sarcopenia prevalence

  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

  3 months

Secondary Outcomes (4)

• BMI

  3 months

• Frailty prevalence

  3 months

• L3-SMI

  3 months

• Life quality

  3 months

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Drug: Silkworm pupa tablets

Control Arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Silkworm pupa tablets DRUG

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

Experimental Arm

Placebo DRUG

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

Control Arm

Eligibility Criteria

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

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

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; Sarcopenia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Xiaosun Liu

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaosun Liu

CONTACT

0086-0571-87237931; xiaosun_liu@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The experimental group uses silkworm pupa tablets; the control group uses a placebo mimicking the silkworm pupa tablets. Statistical personnel will perform blinding for the investigational products according to the requirements. The manufacturer will prepare and provide corresponding food inspection reports according to the requirements for a double-blind design and package accordingly. If the batch number changes during the trial, the manufacturer must provide a new inspection report for the new batch, to be kept by the investigator. Packaging and numbering will be done according to the treatment codes, involving personnel unrelated to the investigators or statisticians. Corresponding numbers will be affixed prominently to the external packaging based on the generated treatment codes. The packaged investigational products will be distributed to the clinical trial centers together.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)