Clinical trial NCT06551675: Effect of Silkworm Pupa Tablets in Gastrointestinal Malignancies at Nutritional Risk Following Radical Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutritional Deficiency
Gastrointestinal Cancer
Frailty Syndrome
Keywords: silkworm pupa tablets
gastrointestinal malignancies
nutritional risk
frailty
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

1. 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).
2. Sample size: totally 120 cases, including 60 cases in the experimental group and 60 cases in the control group.
3. 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.

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.

Primary outcomes:
measure: Body weight
timeFrame: 3 months
measure: Frailty prevalence
timeFrame: 3 months
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: 3 months
measure: L3-SMI
timeFrame: 3 months
measure: Sarcopenia prevalence
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
state: Zhejiang
city: Hangzhou
country: China
facility: he First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou Institute of Medicine Chinese Academy of Sciences
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Xiaosun Liu
role: PRINCIPAL_INVESTIGATOR
References: