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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Body weight
研究概览
简要总结
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.
详细描述
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.
- 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).
- Sample size: totally 120 cases, including 60 cases in the experimental group and 60 cases in the control group.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •Agree to provide peripheral blood, stool, and urine samples for biomarker analysis during the study period.
排除标准
- •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.
研究组 & 干预措施
Silkworm pupa tablets group
Wanshililongbao silkworm pupa tablets.
干预措施: Silkworm pupa tablets (Dietary Supplement)
Control group
Contains 0.5% of the active ingredient of the study product, indistinguishable in appearance.
干预措施: Control product (Dietary Supplement)
结局指标
主要结局
Body weight
时间窗: 3 months
Measured at baseline and 1 month, 2 months, 3 months after enrollment
Frailty prevalence
时间窗: 3 months
The incidence of frailty, using Fried frailty phenotype to assess physical frailty, measured at baseline and 1 month, 2 months, 3 months after enrollment
次要结局
- Body mass index (BMI)(3 months)
- Sarcopenia prevalence(3 months)
- L3-SMI(3 months)
- Quality of life(3 months)
研究者
Xiaosun Liu, MD
Deputy director of gastrointestinal surgery department
First Affiliated Hospital of Zhejiang University