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NCT Number: NCT07554807

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

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).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Placebo

Drug

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

Primary outcomes

  1. Sarcopenia prevalence

    Time frame: 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

Secondary outcomes

  1. BMI

    Time frame: 3 months

    Calculated as weight (kg)/height (m2), measured at baseline and 1 month, 2 months, 3 months after enrollment

  2. Frailty prevalence

    Time frame: 3 months

    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. L3-SMI

    Time frame: 3 months

    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

  4. Life quality

    Time frame: 3 months

    Using the questionnaire of EORTC QLQ-C30 measured at baseline and 1 month, 2 months, 3 months after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaosun Liu

CONTACT

[email protected]

0086-0571-87237931

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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