Clinical trial: NCT05856500
Section: Alternatives
Subsections: 6.If You Don'T Participate In This Trial, Other Treatment Options Are Available

You may choose not to participate in this study, which will not have any adverse effect on your access to the appropriate treatment. We will still inform you of the relevant follow-up precautions.  
Basic nutritional therapy is required for subjects with early malignant upper digestive tract tumors and will be provided even if you choose not to participate in this study.
Clinical trial: NCT05856500
Section: Confidentiality
Subsections: 14. Privacy Protection

Any personal information and data obtained during the trial will be kept strictly confidential. Your blood samples will be identified by a study number, not your name, and information that can identify you will not be disclosed to members outside the study team unless your permission is obtained. All research members and sponsors are requested to keep your identity confidential. Your files will be kept in a locked cabinet and will be accessible to researchers only. To ensure that the study is carried out in accordance with the regulations, the government administration, the sponsor's authorized inspectors or the Ethics committee members will have access to the relevant information about your participation in the study facility as required, but they will ensure that your information will not be disclosed to other parties. Although the results may be published, your identity will not be revealed in these publications. The research data will be stored in Gulou Hospital Affiliated to the School of Medicine of Nanjing University.  
By signing this written informed consent, you consent to the study physician's collection and processing of your personal information for the study (the "Study Data"), including your birth date, gender, and physical health data, which will remain available for use unless your informed consent is withdrawn. If you withdraw your informed consent, your personal data will no longer be used by the study physician and the sponsor, but personal data shared prior to the withdrawal of informed consent can still be used.  
Study physicians will use the study data for clinical research. You have the right to access personal data kept with the study physician and the sponsor, and you also have the right to request the correction of inaccuracies in your personal data; You have the right to withdraw your informed consent at any time. Please contact the study physician if you have any of the above requirements.  
The data will not be transmitted to other countries and regions outside China.
Clinical trial: NCT05856500
Section: Participant Responsibilities
Subsections: 1.Conditions Of Participation In The Study/Trials|5.Participating In The Study Requires Your Cooperation

Inclusion Criteria:
(1) Men and women aged between 18 and 80; (2)Advanced tumors of the upper digestive tract
(patients with untreatable or postoperative recurrence of esophageal and gastric cancer III-IV) are clearly diagnosed; (3) Meet the diagnostic criteria of early cachexia (anorexia and metabolic changes, involuntary body mass reduction ≤5% within 6 months); (4) Radiotherapy, chemotherapy or immunotherapy in our hospital; (5)Understand and fill in a variety of rating scales; (6) Informed consent, voluntary participation in this study.  
Exclusion Criteria:
(1) Neoadjuvant chemotherapy patients;(2) Patients with intestinal obstruction or gastrointestinal bleeding who need complete fasting and parenteral nutrition; (3) Severe heart, lung and renal insufficiency; (4) Coagulopathy; (5) with diabetes and other metabolic diseases; (6) The expected survival time is less than 1 month; (7)Patients with cognitive dysfunction or poor coordination;(8)
Allergy to creatine or curcumin; (9) People with a history of drug abuse; (10) Other conditions that doctors or researchers deem unsuitable for study participation.  
2.Number of people in research/trials 152 subjects will be enrolled.

® Provide accurate medical history and current condition information. ® Tell research is responsible for the doctor you have any health problems during the study period.  
® Research is responsible for the doctor you tell any new drugs, drugs during the study period, to survive, nutrition, or herbs.
® Unless the study doctor is responsible for licensing, should not be taking any drug or treatment, including prescription and over the counter when buying drugs (including vitamins and herbal medicine).  
® According to the doctor's advice, taking the study drug supervision as required.  
to study doctor.  
® Every time in your follow-up, please return the unused drugs and all returned empty package
® Drugs, room temperature storage research will study drug kept out of reach of children, not to
study drug to anyone.  
® Don't participate in other clinical trials. ® Appropriate precautions (during the study period and final dose within 30 days).  
® Follow researchers and research the doctor's guidance.  
® There is any unclear you can ask at any time.  
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Clinical trial: NCT05856500
Section: Participant's Rights
Subsections: 12. Your Rights

Participation in the study is entirely up to you. You may withdraw your informed consent at any time without giving a reason. Whether you make the decision to participate or not, it will not lead to prejudice against you or affect your medical care. If you do not participate in the study, or drop out of the study, there are many alternative treatments that you do not have to choose to participate in to treat your disease. If you need to withdraw from the study, for your safety and objective evaluation of the effects of the drug, please cooperate with the study doctor to complete the relevant evaluation and laboratory examination after the study.  
If you have any questions during the study, please feel free to consult your study physician.  
13. Costs of participating in the study/trial and treatment in case of test-related injuries You will be required to pay the regular treatment fee to participate in this study. The following fees are provided free of charge by the researcher (2975 yuan/person in total):
(1) Preparation expenses A. Cost of enteral nutrition preparation: 50 yuan/person · day ×30 days =1500 yuan/person B. Cost of health food:
Curcumin capsule 2 yuan/person · day ×30 days =60 yuan/person Creatine powder 10 yuan/person · day x 30 days =300 yuan/person
(2) Nutrition management A. Food electronic scale: 10 yuan/person B. Food record book: 5 yuan/person
(3) Test and laboratory processing fees A. Inspection fee (except body components): 1000 yuan/person.  
B. Body composition determination: 50 yuan/person · times ×2 times =100 yuan/person.  
If your health is harmed because of participating in this study, please inform the researcher and we will take necessary medical measures. In this study, creatine powder and curcumin capsules were mainly used, which belong to nutrition and health food. The oral dose was the conventional dose recommended by the instructions. No adverse reactions were reported, and no harm was found. As for some problems, we will deal with them according to the standard.  
You take it orally as directed by the investigator. Your bodily injury was not intentional.  
Notify your researcher at the first sign of injury.  
You followed the medical advice of the researchers.
Clinical trial: NCT05856500
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 7. Possible Side Effects, Risks, And Discomfort Of Participating In The Trial

Your study doctor will monitor creatine and curcumin for side effects. If you experience any side effects or discomfort during the study, it is vital that you report them to the study physician immediately. The research doctor may give you other medications to control side effects. If you or your study physician determines that you cannot tolerate these side effects, the study may be discontinued entirely, and you may withdraw from the study.  
In this study, no definite adverse reactions have been reported for the two oral health foods, and a few of them may cause nausea, vomiting or abdominal distension, which disappear automatically after discontinuation.
Clinical trial: NCT05856500
Section: Purpose of Research
Subsections: Purpose

(1) To study whether creatine combined with curcumin can improve the inflammatory state of the cachexia in the early stage of upper gastrointestinal tumors, correct the disorder of nutritional metabolism, and improve the nutritional status.  
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(2) To study whether creatine combined with curcumin can improve the quality of life and prognosis of early cachexia in upper digestive tract tumors, to provide a nutritional intervention mode for early cachexia in the clinic.
Clinical trial: NCT05856500
Section: Voluntary Participation
Subsections: 3. Is It Necessary To Participate In And Complete The Test?

Whether or not you participate in this study is of your own free will. If you decide to participate, you will be asked to sign an informed consent form and will receive a copy of this informed consent form. If you are enrolled in the study, you may still request withdrawal at any time if your withdrawal will not affect your standard care.  
4.Research/test process Detection items and time schedule  
| Classification   | Item               | 0   | 0.5m   | 1m   | 3m   |
|------------------|--------------------|-----|--------|------|------|
| blood routine    | √                  | -   | √      | √    |      |
| Serological      | biochemical set    | √   | -      | √    | √    |
| indicators       | prealbumin         | √   | -      | √    | √    |
| transferrin      | √                  | -   | √      | √    |      |
| Body             | CT scans skeletal  | √   | -      | √    | √    |
| composition      | muscle index at L3 |     |        |      |      |  
| Informed consent version:2.0           | Version date:May 12,2023                       |    |     |    |    |
|-----------------------------------------|--------------------------------------------------|----|-----|----|----|
| index                                   | cross section                                    | √  | -   | √  | √  |
| BIA measures  muscle mass Serum insulin | √                                                | -  | √   | √  |    |
| Inflammatory                            | IL-6                                             | √  | -   | √  | √  |
| metabolic  indicators                   | TNF-α                                            | √  | -   | √  | √  |
| lactic acid                             | √                                                | -  | √   | √  |    |
| PETCT(SUV)                            | p.r                                              | -  | p.r | -  |    |
| Weight                                  | √                                                | √  | √   | √  |    |
| Physical  measurements                  | grip strength                                    | √  | √   | √  | √  |
| skin fold thickness                     | √                                                | √  | √   | √  |    |
| √                                       | √                                                | √  | √   |    |    |
| upper arm  circumference                |                                                  |    |     |    |    |
| nutrition                               | intake                                           | √  | √   | √  | √  |
| PG-SGA score                            | √                                                | √  | √   | √  |    |
| assessment                              | √                                                | √  | √   | √  |    |
| Therapy(FAACT)                        |                                                  |    |     |    |    |
| Questionnaire                           | Functional                                       |    |     |    |    |
| Survey                                  | Assessment of  Anorexia/Cachexia  ADL evaluation | √  | √   | √  | √  |
| scale                                   |                                                  |    |     |    |    |  
Clinical data of patients with advanced esophageal cancer and gastric cancer combined with early cachexia were collected. Abdominal CT scan was performed to measure skeletal muscle area and Inflammatory metabolic markers including serum insulin, IL-6, TNF-α, lactic acid, and PETCT were assessed for metabolism. NRS2002 and PG-SGA scores were performed. According to the standard 5 body weight, dietitians formulated a diet for all enrolled subjects. According to the ESPEN guidelines, the dietary energy intake was 30 to 35kcal/kg·d, the protein intake was 1.0 to 2.0g/kg·d, and the insufficient portion was given oral nutrition supplement and/or whey protein powder supplement. Or enteral nutrition supplementation for patients requiring tube feeding. The enrolled subjects were divided into group A control group and Group B intervention group according to the patients' own wishes by non-randomization principle.  
Group A intervention group: Basic nutritional support was provided.  
Group B control group: In addition to basic nutrition, oral creatine powder 5g qd, curcumin capsule 2g bid, intervention time 1 month.  
The intake, complications and survival were followed up by telephone at 3 weeks; physical indicators, nutritional assessment, anorexia, and anorexia fluid quality Questionnaire (FAACT) and QoL scale were followed up at 2 weeks; nutritional serum indicators, body composition indicators, inflammatory metabolism indicators, physical indicators, nutritional assessment, FAACT and QoL scale were reviewed at 4 weeks. Evaluation of effect. The long-term survival, re-hospitalization and hospitalization expenses were investigated 3 months later. To evaluate the effect of creatine combined with curcumin on improving the nutritional status, metabolic level and clinical prognosis of the early stage of upper gastrointestinal neoplasm. Note: Weight is calculated by standard weight: Standard weight (kg) = height (cm)-105.