Nutritional DeficiencyNCT06551675
Effect of Silkworm Pupa Tablets in Gastrointestinal Malignancies at Nutritional Risk Following Radical Surgery
A study testing Silkworm pupa tablets in people with Nutritional Deficiency and Gastrointestinal Cancer, run by Xiaosun Liu, MD at 4 sites in China.
Trial summary
This is a randomized, double-blind, very low dose parallel-controlled, prospective, multi-center trial evaluating the improvement of nutritional status and frailty with silkworm pupa tablets after radical resection of gastrointestinal malignancies for 3 months intervention. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutritional Deficiency, Gastrointestinal Cancer, Frailty Syndrome
- 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
- 120 participants
- Where
- 4 sitesChina
- Study dates
- 14 Aug 2024to 26 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Voluntarily participate in the clinical study, fully understand the study and sign the informed consent form (ICF); willing and able to follow and complete all trial procedures.
- Gender unrestricted, age at the time of signing ICF: ≥18 years, ≤80 years.
- Diagnosed with a malignant gastrointestinal tumor, including gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer, and has undergone radical surgical resection. If necessary, perioperative systemic treatment has been completed by the time of screening.
- At the time of screening, a nutritional risk score of ≥3 (based on the NRS 2002 nutritional risk screening tool) .
- In good general condition, with an ECOG performance status score of ≤2.
- Agree to provide peripheral blood, stool, and urine samples for biomarker analysis during the study period.
Who cannot join
- At the time of screening, presence of tumor recurrence or metastasis.
- At the time of screening, presence of another active malignancy requiring concurrent treatment.
- Expected survival of ≤3 months.
- Unable to take oral nutrition, requiring enteral feeding tubes, or having malabsorption syndrome or any condition affecting gastrointestinal absorption; e.g., chronic diarrhea (watery stools; defecation frequency ≥5 times a day).
- Patients who are planning a pregnancy, are pregnant, or are breastfeeding.
- Allergic to any known components of the trial materials.
- Presence of serious primary diseases of the heart, brain, lungs, liver, kidneys, endocrine, hematological, neurological, or other systems, or other acute or 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 associated with participation in the study, or patients deemed unsuitable for participation by the researchers.
Trial locations and contacts
4 sites in 1 country.
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
Official title: A Randomized, Double-blind, Very Low Dose Parallel-controlled, Prospective, Multi-center Trial Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Tablets After Radical Resection of Gastrointestinal Malignancies
This is a randomized, double-blind, very low dose parallel-controlled, prospective, multi-center trial evaluating the improvement of nutritional status and frailty with silkworm pupa tablets after radical resection of gastrointestinal malignancies for 3 months intervention. The primary endpoints are body weight and frailty prevalence, The secondary endpoints are body mass index (BMI), skeletal muscle index (SMI) at the third lumbar vertebra (L3-SMI), sarcopenia prevalence and quality of life.
Read the detailed description
Previous study has indicated that silkworms pupae extracts may increase muscle mass and strength, here we conduct a randomized, double-blind, very low dose parallel-controlled, prospective, multi-center trial.
- Study population: malignant gastrointestinal tumors, including gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer, and has undergone radical surgical resection. If necessary, perioperative systemic treatment has been completed by the time of screening, and has a nutritional risk score of ≥3 (based on the NRS 2002 nutritional risk screening tool).
- Sample size: totally 120 cases, including 60 cases in the experimental group and 60 cases in the control group.
- Research content: In this study, participants will begin taking the trial product or control immediately upon enrollment, with a treatment duration of 3 months.Experimental Group: Wanshililongbao silkworm pupa tablets. Control Group: contains 0.5% of the active ingredient of the trial product, indistinguishable in appearance.
- Being tested
- Silkworm pupa tablets, Control product
- Keywords
- silkworm pupa tablets, gastrointestinal malignancies, nutritional risk, frailty
- Medical subject headings
- Malnutrition, Gastrointestinal Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silkworm pupa tabletsDietary supplement
Participants will begin taking the silkworm pupa tablets immediately upon enrollment, 1200mg/tablet, two tablets a time, twice a day (BID), with a treatment duration of three months.
Control productDietary supplement
The sham comparator contains 0.5% of the active ingredient of the study product, indistinguishable in appearance. Participants will begin taking the control immediately upon enrollment, 1200mg/tablet, two tablets a time, twice a day (BID), with a treatment duration of three months.
| Study group | Role | What they receive |
|---|---|---|
| Silkworm pupa tablets group | Experimental | Wanshililongbao silkworm pupa tablets. Receives: Dietary Supplement: Silkworm pupa tablets |
| Control group | Sham comparator | Contains 0.5% of the active ingredient of the study product, indistinguishable in appearance. Receives: Dietary Supplement: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
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
Secondary outcomes (5)
Body mass index (BMI)
Calculated as weight (kg)/height (m2), 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
Sarcopenia prevalence
The incidence of sarcopenia, using the diagnostic criteria for sarcopenia published by the Asian Sarcopenia Working Group (AWGS) in 2019 or L3-SMI criteria, measured at baseline and 1 month, 2 months, 3 months after enrollment
Measured: 3 months
Quality of life
Using the questionnaire of EORTC QLQ-C30 measured at baseline and 1 month, 2 months, 3 months after enrollment
Measured: 3 months
Quality of life
Using the questionnaire of EORTC QLQ-STO22, 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 posted13 Aug 2024
- Study start14 Aug 2024
- Primary completion26 Oct 2025
- Study completion26 Oct 2025
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaosun Liu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaosun Liu, MD, First Affiliated Hospital of Zhejiang University
- Investigators
- Xiaosun Liu, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551675
- Sponsor's protocol ID
- IIT20240064C
- Status last verified
- May 2026
- First submitted
- 6 Aug 2024
- Last updated
- 27 May 2026
- Results posted
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Very Low Dose Parallel-controlled, Prospective, Multi-center Trial Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Tablets After Radical Resection of Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT06551675
- Acronym / sponsor ID
- IIT20240064C
- Keywords
- silkworm pupa tablets, gastrointestinal malignancies, nutritional risk, frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Xiaosun Liu, MDUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 26 Oct 2025 (actual)
- Study completion
- 26 Oct 2025 (actual)
- First posted
- 13 Aug 2024 (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, very low dose parallel-controlled, prospective, multi-center trial evaluating the improvement of nutritional status and frailty with silkworm pupa tablets after radical resection of gastrointestinal malignancies for 3 months intervention. The primary endpoints are body weight and frailty prevalence, The secondary endpoints are body mass index (BMI), skeletal muscle index (SMI) at the third lumbar vertebra (L3-SMI), sarcopenia prevalence and quality of life.
Detailed description
Previous study has indicated that silkworms pupae extracts may increase muscle mass and strength, here we conduct a randomized, double-blind, very low dose parallel-controlled, prospective, multi-center trial.
- Study population: malignant gastrointestinal tumors, including gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer, and has undergone radical surgical resection. If necessary, perioperative systemic treatment has been completed by the time of screening, and has a nutritional risk score of ≥3 (based on the NRS 2002 nutritional risk screening tool).
- Sample size: totally 120 cases, including 60 cases in the experimental group and 60 cases in the control group.
- Research content: In this study, participants will begin taking the trial product or control immediately upon enrollment, with a treatment duration of 3 months.Experimental Group: Wanshililongbao silkworm pupa tablets. Control Group: contains 0.5% of the active ingredient of the trial product, indistinguishable in appearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silkworm pupa tablets group | Experimental | Dietary Supplement: Silkworm pupa tabletsWanshililongbao silkworm pupa tablets. |
| Control group | Sham comparator | Dietary Supplement: Control productContains 0.5% of the active ingredient of the study product, indistinguishable in appearance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily participate in the clinical study, fully understand the study and sign the informed consent form (ICF); willing and able to follow and complete all trial procedures.
- Gender unrestricted, age at the time of signing ICF: ≥18 years, ≤80 years.
- Diagnosed with a malignant gastrointestinal tumor, including gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer, and has undergone radical surgical resection. If necessary, perioperative systemic treatment has been completed by the time of screening.
- At the time of screening, a nutritional risk score of ≥3 (based on the NRS 2002 nutritional risk screening tool) .
- In good general condition, with an ECOG performance status score of ≤2.
Key exclusion criteria (8 listed)
- At the time of screening, presence of tumor recurrence or metastasis.
- At the time of screening, presence of another active malignancy requiring concurrent treatment.
- Expected survival of ≤3 months.
- Unable to take oral nutrition, requiring enteral feeding tubes, or having malabsorption syndrome or any condition affecting gastrointestinal absorption; e.g., chronic diarrhea (watery stools; defecation frequency ≥5 times a day).
- Patients who are planning a pregnancy, are pregnant, or are 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 tabletsParticipants will begin taking the silkworm pupa tablets immediately upon enrollment, 1200mg/tablet, two tablets a time, twice a day (BID), with a treatment duration of three months. | Dietary supplement | Silkworm pupa tablets group |
| Control productThe sham comparator contains 0.5% of the active ingredient of the study product, indistinguishable in appearance. Participants will begin taking the control immediately upon enrollment, 1200mg/tablet, two tablets a time, twice a day (BID), with a treatment duration of three months. | Dietary supplement | Control group |
Primary outcome
Body weight
Time frame: 3 months
Measured at baseline and 1 month, 2 months, 3 months after enrollment
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
5 secondary outcomes
Body mass index (BMI)
Time frame: 3 months
L3-SMI
Time frame: 3 months
Sarcopenia prevalence
Time frame: 3 months
Quality of life
Time frame: 3 months
Quality of life
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 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. This study is not recruiting at the moment.
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 study testing Silkworm pupa tablets in people with Nutritional Deficiency and Gastrointestinal Cancer, run by Xiaosun Liu, MD 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: finished, as of the sponsor's last update on 27 May 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 3 months). The study lists 2 primary outcomes in all. 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 27 May 2026.