A Prospective Open Controlled Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 主要终点
- Appendicular skeletal muscle mass index(kg/㎡)
研究概览
简要总结
Cachexia is a common complication of various advanced malignant tumors, which seriously affects the quality of life and survival time of patients. In view of the clinical problem of non-nutritional response in patients with cachexia, the investigators plan to carry out a clinical case-control study on the intervention of creatine combined with curcumin in participants with cachexia. On the whole, the investigators limited the study subjects to upper digestive tract tumors and diagnosed participants with early cachexia. The main purpose of this study is to determine whether the combination of the two can play a positive and stable role in inhibiting the inflammation of cachexia and improving metabolic status, so that basic nutrition can play a role, in order to reduce the level of skeletal muscle consumption, maintain weight, improve quality of life, save medical costs and extend survival time.
详细描述
This is a prospective open controlled study. The intervention is targeted at participants with early cachexia in upper gastrointestinal tumors.Both control group and intervention group receive basic nutritional support. On the basis of this, the intervention group will be given creatine and curcumin orally.The purpose is to investigate whether creatine combined with curcumin can improve the inflammatory and the nutritional state, correct the disorder of nutrient metabolism and improve the prognosis of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical diagnosis of advanced tumors of the upper digestive tract with untreatable or postoperative recurrence of esophageal and gastric cancer III-IV
- •Meet the diagnostic criteria of early cachexia (anorexia and metabolic changes, involuntary body mass reduction ≤5% within 6 months)
- •Radiotherapy, chemotherapy or immunotherapy in our hospital
- •Understand and fill in a variety of rating scales
- •Informed consent, voluntary participation in this study
排除标准
- •Neoadjuvant chemotherapy patients
- •Intestinal obstruction or gastrointestinal bleeding
- •Severe heart, lung and renal insufficiency
- •Coagulopathy
- •Clinical diagnosis with diabetes and other metabolic diseases
- •The expected survival time is less than 1 month
- •With cognitive dysfunction or poor coordination
- •Allergy to creatine or curcumin
- •With a history of drug abuse
- •Doctors or researchers deem unsuitable for study participation
结局指标
主要结局
Appendicular skeletal muscle mass index(kg/㎡)
时间窗: 1-month
Appendicular skeletal muscle mass(ASM)is measured by bioelectrical impedance analysis(BIA), the ASM index (ASM/height²)is calculated.
L3 skeletal muscle index(c㎡/㎡)
时间窗: 1-month
CT scans L3 cross-sectional skeletal muscle area/height²
次要结局
- Albumin concentration(g/L)(1-month)
- PG-SGA score(1-month)
- Functional Assessment of Anorexia/Cachexia Therapy(FAACT)(1-month)
- Pre-albumin concentration(mg/L)(1-month)
- Body Mass Index(kg/㎡)(1-month)
- Nutrition intake level(%)(1-month)
- Survival rate(%)(3-month)