Using silkworm pupa tablets to improve nutrition in patients with gastrointestinal cancer after surgery
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 study is testing if taking silkworm pupa tablets can help improve nutrition and overall well-being in patients recovering from surgery for gastrointestinal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 5 sites (Hangzhou, Zhejiang and 4 other locations) |
| Trial ID | NCT06551675 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of silkworm pupa tablets on nutritional status and frailty in patients who have undergone radical surgery for gastrointestinal malignancies. It is a randomized, double-blind, parallel-controlled trial involving 120 participants, with half receiving the silkworm pupa tablets and the other half receiving a control product. The study will assess changes in body weight, frailty prevalence, and quality of life over a 3-month intervention period. Participants must have a nutritional risk score of ≥3 and be in good general condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have undergone radical surgery for gastrointestinal malignancies and have a nutritional risk score of ≥3.
Not a fit: Patients with tumor recurrence or metastasis at the time of screening will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve nutritional status and quality of life for patients recovering from gastrointestinal cancer surgery.
How similar studies have performed: Previous studies have suggested that silkworm extracts may enhance muscle mass and strength, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Hangzhou, Zhejiang and 4 other locations
- Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- he First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- The Second Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- Hangzhou Institute of Medicine Chinese Academy of Sciences — Hangzhou, China (Recruiting)
Study contacts
- Principal investigator: Xiaosun Liu — First Affiliated Hospital of Zhejiang University
- Study coordinator: Xiaosun Liu
- Email: xiaosun_liu@163.com
- Phone: 0086-0571-87237931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.