A Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors

Not Applicable

Not yet recruiting

Conditions: Stage III Esophageal Cancer
Stage IV Gastric Cancer
Stage IIIB Gastric Cancer
Stage IIIA Gastric Cancer
Stage IV Esophageal Cancer

Interventions: Dietary Supplement: basic nutrition
Dietary Supplement: oral supplement of creatine and curcumin

Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
basic nutrition	basic nutrition	basic nutrition treatment, energy 30-35 kcal/kg, protein 1.0-2.0 g/kg, total nutrition and/or whey protein oral nutrition supplement or tube feeding enteral nutrition supplement if diet deficiency;
oral supplement of creatine and curcumin	oral supplement of creatine and curcumin	On the basis of basic nutrition in group A, creatine 5g/d and curcumin 4g/d are orally added, and the intervention time is 1 month.

Primary Outcome Measures

Name	Time	Method
Appendicular skeletal muscle mass index(kg/㎡)	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㎡/㎡)	1-month	CT scans L3 cross-sectional skeletal muscle area/height²

Secondary Outcome Measures

Name	Time	Method
Albumin concentration(g/L)	1-month	Serological albumin concentration
PG-SGA score	1-month	Scored Patient-Generated Subjective Global Assessment(PG-SGA)：(0-1，stage A；2-8，stage B；≥9，stageC)
Functional Assessment of Anorexia/Cachexia Therapy(FAACT)	1-month	Anorexia/Cachexia Sub-scale-12：score 0～24，Anorexia/Cachexia
Pre-albumin concentration(mg/L)	1-month	Serological pre-albumin concentration
Body Mass Index(kg/㎡)	1-month	body weight/height²
Nutrition intake level(%)	1-month	Investigate the ratio of actual energy and protein intake levels to target intake levels
Survival rate(%)	3-month	(Number of surviving cases after 3 month of follow-up)/(number of cases at the beginning of follow-up) ×100%