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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stage IV Gastric Cancer; Stage IV Esophageal Cancer; Stage IIIA Gastric Cancer; Stage IIIB Gastric Cancer; Stage III Esophageal Cancer
• Intervention / Treatment: Dietary supplement: basic nutrition; Dietary supplement: oral supplement of creatine and curcumin

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaotian Chen; Phone Number: 13851752678; Email: chenxiaotian@njglyy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: basic nutrition; 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;	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.
Experimental: oral supplement of creatine and curcumin; 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.	Dietary supplement: oral supplement of creatine and curcumin; Creatine and curcumin are orally added other than basic nutrition treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-albumin concentration(mg/L)	Serological pre-albumin concentration	0-month
Pre-albumin concentration(mg/L)	Serological pre-albumin concentration	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

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): August 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Creatine; Cur-cumin; Early Cachexia
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Stomach Diseases; Nutrition Disorders; Body Weight; Head and Neck Neoplasms; Esophageal Diseases; Body Weight Changes; Emaciation; Weight Loss; Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Esophageal Neoplasms; Wasting Syndrome; Cachexia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 2022-223-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No