NCT06551675

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Xiaosun Liu, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nutritional Deficiency
• Gastrointestinal Cancer
• Frailty Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Silkworm pupa tablets	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.
DIETARY_SUPPLEMENT	Control product	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.

Timeline

• Start date: 2024-08-14
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2024-08-13
• Last updated: 2025-08-12

Locations

4 sites across 1 country: China