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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Open Controlled Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors

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

Intervention / Treatment
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* Dietary Supplement: basic nutrition
* Dietary Supplement: oral supplement of creatine and curcumin


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: basic nutrition<br>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; | Dietary Supplement: basic nutrition<br>* An adequate supply of energy and protein in diet, oral nutrition supplement or tube feeding enteral nutrition supplement when diet is deficient.<br>|
| Experimental: oral supplement of creatine and curcumin<br>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. | Dietary Supplement: oral supplement of creatine and curcumin<br>* Creatine and curcumin are orally added other than basic nutrition treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| L3 skeletal muscle index(c㎡/㎡) | CT scans L3 cross-sectional skeletal muscle area/height² | 0-month | 
| L3 skeletal muscle index(c㎡/㎡) | CT scans L3 cross-sectional skeletal muscle area/height² | 1-month | 
| Appendicular skeletal muscle mass index(kg/㎡) | Appendicular skeletal muscle mass(ASM)is measured by bioelectrical impedance analysis(BIA), the ASM index (ASM/height²)is calculated. | 0-month | 
| Appendicular skeletal muscle mass index(kg/㎡) | Appendicular skeletal muscle mass(ASM)is measured by bioelectrical impedance analysis(BIA), the ASM index (ASM/height²)is calculated. | 1-month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Creatine, Cur-cumin, Early Cachexia