Effect of Silkworm Pupa Tablets in Gastrointestinal Malignancies at Nutritional Risk Following Radical Surgery

Launched by XIAOSUN LIU, MD · Aug 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how silkworm pupa tablets may help improve nutritional health and reduce frailty in patients who have had surgery for gastrointestinal cancers, such as stomach, colon, esophagus, or pancreas cancer. The trial will last for three months, and researchers will look at changes in body weight and overall health, as well as other factors like muscle mass and quality of life.

To be eligible for this study, participants should be between 18 and 80 years old, have been diagnosed with a gastrointestinal cancer, and have recently undergone surgery to remove the tumor. They should also have a nutritional risk score indicating they need help with their nutrition. Participants will need to provide samples of blood, stool, and urine for analysis during the study. It’s important to note that individuals with active cancer that has spread or other serious health issues may not qualify for the study. If you decide to participate, you can expect regular check-ins and support as you take the tablets and share your health progress with the research team.

Gender

ALL

Eligibility 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.