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Not yet recruiting 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

Phase III Interventional Nutritional Deficiency Gastrointestinal Cancers Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Silkworm pupa tablets, Placebo.
Who it may be relevant to
Registry conditions: Nutritional Deficiency, Gastrointestinal Cancers, Sarcopenia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

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

Primary outcome measures

  • Sarcopenia prevalence [Time frame: 3 months]
Secondary outcome measures (4)
  • BMI [Time frame: 3 months]
  • Frailty prevalence [Time frame: 3 months]
  • L3-SMI [Time frame: 3 months]
  • Life quality [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 4 centers
  • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University — Hangzhou
  • The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou
  • The Second Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou
  • Hangzhou Institute of Medicine Chinese Academy of Sciences — Hangzhou

Identifiers

NCT: NCT07554807 · IIT20250149C-R1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗