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).
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
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)
Parallel
Silkworm pupa tablets
DrugFor Experimental arm: Dietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals
Placebo
DrugControl arm: Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals.
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
BMI
Calculated as weight (kg)/height (m2), measured at baseline and 1 month, 2 months, 3 months after enrollment
Frailty prevalence
The incidence of frailty, using Fried frailty phenotype to assess physical frailty, measured at baseline and 1 month, 2 months, 3 months after enrollment
L3-SMI
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
Life quality
Using the questionnaire of EORTC QLQ-C30 measured at baseline and 1 month, 2 months, 3 months after enrollment
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First Affiliated Hospital of Zhejiang University
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
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