Stage IV Gastric Cancer Clinical Trial
Official title:
A Prospective Open Controlled Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors
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.
Status | Not yet recruiting |
Enrollment | 152 |
Est. completion date | December 31, 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
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: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | L3 skeletal muscle index(c?/?) | CT scans L3 cross-sectional skeletal muscle area/height² | 0-month | |
Primary | L3 skeletal muscle index(c?/?) | CT scans L3 cross-sectional skeletal muscle area/height² | 1-month | |
Primary | 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 | |
Primary | 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 | Pre-albumin concentration(mg/L) | Serological pre-albumin concentration | 0-month | |
Secondary | Pre-albumin concentration(mg/L) | Serological pre-albumin concentration | 1-month | |
Secondary | Albumin concentration(g/L) | Serological albumin concentration | 0-month | |
Secondary | Albumin concentration(g/L) | Serological albumin concentration | 1-month | |
Secondary | Body Mass Index(kg/?) | body weight/height² | 0-month | |
Secondary | Body Mass Index(kg/?) | body weight/height² | 1-month | |
Secondary | Nutrition intake level(%) | Investigate the ratio of actual energy and protein intake levels to target intake levels | 0-month | |
Secondary | Nutrition intake level(%) | Investigate the ratio of actual energy and protein intake levels to target intake levels | 1-month | |
Secondary | PG-SGA score | Scored Patient-Generated Subjective Global Assessment(PG-SGA):(0-1,stage A;2-8,stage B;=9,stageC) | 0-month | |
Secondary | PG-SGA score | Scored Patient-Generated Subjective Global Assessment(PG-SGA):(0-1,stage A;2-8,stage B;=9,stageC) | 1-month | |
Secondary | Functional Assessment of Anorexia/Cachexia Therapy(FAACT) | Anorexia/Cachexia Sub-scale-12:score 0~24,Anorexia/Cachexia | 0-month | |
Secondary | Functional Assessment of Anorexia/Cachexia Therapy(FAACT) | Anorexia/Cachexia Sub-scale-12:score 0~24,Anorexia/Cachexia | 1-month | |
Secondary | Survival rate(%) | (Number of surviving cases after 1 month of follow-up)/(number of cases at the beginning of follow-up) ×100% | 1-month | |
Secondary | Survival rate(%) | (Number of surviving cases after 3 month of follow-up)/(number of cases at the beginning of follow-up) ×100% | 3-month |
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