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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| basic nutrition | Placebo Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| basic nutrition | Dietary Supplement | An adequate supply of energy and protein in diet, oral nutrition supplement or tube feeding enteral nutrition supplement when diet is deficient. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-albumin concentration(mg/L) | Serological pre-albumin concentration | 0-month |
| Pre-albumin concentration(mg/L) | Serological pre-albumin concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaotian Chen | Contact | 13851752678 | chenxiaotian@njglyy.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2023 |
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| oral supplement of creatine and curcumin | Dietary Supplement | Creatine and curcumin are orally added other than basic nutrition treatment. |
|
| 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 |
| May 12, 2023 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2023 | May 12, 2023 | ICF_003.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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