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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05856500
• Other study ID #: 2022-223-02
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cachexia
• Digestive System Neoplasms
• Esophageal Neoplasms
• Gastrointestinal Neoplasms
• Stage III Esophageal Cancer
• Stage IIIA Gastric Cancer
• Stage IIIB Gastric Cancer
• Stage IV Esophageal Cancer
• Stage IV Gastric Cancer
• Stomach Neoplasms

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