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| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Dietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals |
|
| Control Arm | Placebo Comparator | Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Calculated as weight (kg)/height (m2), measured at baseline and 1 month, 2 months, 3 months after enrollment | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaosun Liu | Contact | 0086-0571-87237931 | xiaosun_liu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaosun Liu | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University | Hangzhou | Zhejiang | 310000 | China | ||
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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.
| Placebo | Drug | Control arm: Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals. |
|
| 3 months |
| 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 | 3 months |
| Life quality | Using the questionnaire of EORTC QLQ-C30 measured at baseline and 1 month, 2 months, 3 months after enrollment | 3 months |
| The First Affiliated Hospital, College of Medicine, Zhejiang University |
| Hangzhou |
| Zhejiang |
| 310003 |
| China |
| The Second Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
| Hangzhou Institute of Medicine Chinese Academy of Sciences | Hangzhou | China |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D005770 | Gastrointestinal Neoplasms |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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