A Randomized, Double-blind, Placebo-controlled, Prospective, Multi-center Trial Evaluating the Improvement of Nutritional Status and Sarcopenia With Silkworm Pupa Tablets in Patients With Malignancies
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
- 试验地点
- 4
- 主要终点
- Sarcopenia prevalence
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group, prospective, multi-center clinical trial, to evaluate the efficacy of silkworm pupa tablets in improving nutritional status and sarcopenia in patients with malignancies who have completed comprehensive treatment. All participants will be randomly assigned (1:1) to either experimental group (n=240): dietary advice + Wanshili Longbao Silkworm Pupa Tablets (main ingredients: freeze-dried active mulberry cocoon pupa powder, maltitol, milk mineral salt, mannitol, maltodextrin), 2 tablets three times daily before meals for 3 months, or control group (n=240): dietary advice + placebo (identical appearance), 2 tablets three times daily before meals for 3 months. The primary endpoint is sarcopenia prevalence at 3 months (based on AWGS 2019 criteria: muscle strength, muscle mass, and physical function).
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
- Double (Participant, Investigator)
盲法说明
The experimental group uses silkworm pupa tablets; the control group uses a placebo mimicking the silkworm pupa tablets. Statistical personnel will perform blinding for the investigational products according to the requirements. The manufacturer will prepare and provide corresponding food inspection reports according to the requirements for a double-blind design and package accordingly. If the batch number changes during the trial, the manufacturer must provide a new inspection report for the new batch, to be kept by the investigator. Packaging and numbering will be done according to the treatment codes, involving personnel unrelated to the investigators or statisticians. Corresponding numbers will be affixed prominently to the external packaging based on the generated treatment codes. The packaged investigational products will be distributed to the clinical trial centers together.
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
- •fully understand and sign the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures
- •Any gender, age at ICF signing: ≥ 18 years, ≤ 80 years
- •Confirmed diagnosis of malignancy
- •At screening/ enrollment, meet the definition of sarcopenia according to the 2019 Asian Working Group for Sarcopenia
- •Generally good condition, ECOG performance status ≤ 2
- •Agree to provide peripheral blood, stool, and urine samples for biomarker analysis during the study
排除标准
- •Presence of gastrointestinal obstruction preventing oral intake at screening/enrollment
- •Use of immunosuppressants at screening/enrollment
- •Life expectancy ≤ 3 months
- •Presence of malabsorption syndrome or any condition affecting gastrointestinal absorption, e.g., chronic diarrhea (watery stools; daily stool frequency ≥ 5 times)
- •Patients planning pregnancy, pregnant, or breastfeeding
- •Known allergy to any component of the investigational products
- •Presence of severe primary diseases of the heart, brain, lung, liver, kidney, endocrine, blood, nervous systems or other acute/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 of participating in the study, or patients deemed unsuitable for the study by the investigator
研究组 & 干预措施
Experimental Arm
Dietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals
干预措施: Silkworm pupa tablets (Drug)
Control Arm
Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals.
干预措施: Placebo (Drug)
结局指标
主要结局
Sarcopenia prevalence
时间窗: 3 months
Participants completed all comprehensive treatment, who met the 2019 Asian Working Group for Sarcopenia (AWGS) diagnostic criteria. Sarcopenia was evaluated at baseline and 1 month, 2 months, 3 months after enrollment
次要结局
- BMI(3 months)
- Frailty prevalence(3 months)
- L3-SMI(3 months)
- Life quality(3 months)