Status:
ACTIVE_NOT_RECRUITING
Effect of Silkworm Pupa Tablets in Gastrointestinal Malignancies at Nutritional Risk Following Radical Surgery
Lead Sponsor:
Xiaosun Liu, MD
Conditions:
Nutritional Deficiency
Gastrointestinal Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 rad...
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-cent...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06551675
Start Date
August 14 2024
End Date
November 1 2025
Last Update
August 12 2025
Active Locations (4)
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1
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China, 310000
2
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
3
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
4
Hangzhou Institute of Medicine Chinese Academy of Sciences
Hangzhou, China