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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05856500
Other study ID # 2022-223-02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2025

Study information

Verified date December 2022
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact Xiaotian Chen
Phone 13851752678
Email chenxiaotian@njglyy.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Intervention

Dietary Supplement:
basic nutrition
An adequate supply of energy and protein in diet, oral nutrition supplement or tube feeding enteral nutrition supplement when diet is deficient.
oral supplement of creatine and curcumin
Creatine and curcumin are orally added other than basic nutrition treatment.

Locations

Country Name City State
n/a

Sponsors (1)

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

Outcome

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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