Nutritional DeficiencyPhase 3NCT07554807
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
A Phase 3 study testing Silkworm pupa tablets in people with Nutritional Deficiency and Gastrointestinal Cancers, run by First Affiliated Hospital of Zhejiang University at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutritional Deficiency, Gastrointestinal Cancers, Sarcopenia
- What is being tested?
- Silkworm pupa tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 4 sitesChina
- Study dates
- 1 Apr 2026to 31 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, 310000
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Hangzhou Institute of Medicine Chinese Academy of Sciences
Hangzhou
About this study
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
- Nutritional Deficiency, Gastrointestinal Cancers, Sarcopenia
- Being tested
- Silkworm pupa tablets, Placebo
- Keywords
- silkworm pupa tablets, gastrointestinal malignancies, nutritional risk
- Medical subject headings
- Malnutrition, Gastrointestinal Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silkworm pupa tabletsDrug
For Experimental arm: Dietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals
PlaceboDrug
Control arm: Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Dietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals Receives: Drug: Silkworm pupa tablets |
| Control Arm | Placebo comparator | Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
BMI
Calculated as weight (kg)/height (m2), measured at baseline and 1 month, 2 months, 3 months after enrollment
Measured: 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
Measured: 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
Measured: 3 months
Life quality
Using the questionnaire of EORTC QLQ-C30 measured at baseline and 1 month, 2 months, 3 months after enrollment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Sponsor
- Investigators
- Xiaosun Liu, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554807
- Sponsor's protocol ID
- IIT20250149C-R1
- Status last verified
- Mar 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07554807
- Acronym / sponsor ID
- IIT20250149C-R1
- Conditions
- Nutritional Deficiency, Gastrointestinal Cancers, Sarcopenia
- Keywords
- silkworm pupa tablets, gastrointestinal malignancies, nutritional risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Silkworm pupa tabletsDietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals |
| Control Arm | Placebo comparator | Drug: PlaceboDietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silkworm pupa tabletsFor Experimental arm: Dietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals | Drug | Experimental Arm |
| PlaceboControl arm: Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals. | Drug | Control Arm |
Primary outcome
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
4 secondary outcomes
BMI
Time frame: 3 months
Frailty prevalence
Time frame: 3 months
L3-SMI
Time frame: 3 months
Life quality
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaosun Liu principal investigator
First Affiliated Hospital of Zhejiang University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silkworm pupa tablets in people with Nutritional Deficiency and Gastrointestinal Cancers, run by First Affiliated Hospital of Zhejiang University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaosun Liu (0086-0571-87237931, xiaosun_liu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenia prevalence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.