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

May 16, 2023 updated by: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
L3 skeletal muscle index(c㎡/㎡)
Time Frame: 0-month
CT scans L3 cross-sectional skeletal muscle area/height²
0-month
L3 skeletal muscle index(c㎡/㎡)
Time Frame: 1-month
CT scans L3 cross-sectional skeletal muscle area/height²
1-month
Appendicular skeletal muscle mass index(kg/㎡)
Time Frame: 0-month
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/㎡)
Time Frame: 1-month
Appendicular skeletal muscle mass(ASM)is measured by bioelectrical impedance analysis(BIA), the ASM index (ASM/height²)is calculated.
1-month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pre-albumin concentration(mg/L)
Time Frame: 0-month
Serological pre-albumin concentration
0-month
Pre-albumin concentration(mg/L)
Time Frame: 1-month
Serological pre-albumin concentration
1-month
Albumin concentration(g/L)
Time Frame: 0-month
Serological albumin concentration
0-month
Albumin concentration(g/L)
Time Frame: 1-month
Serological albumin concentration
1-month
Body Mass Index(kg/㎡)
Time Frame: 0-month
body weight/height²
0-month
Body Mass Index(kg/㎡)
Time Frame: 1-month
body weight/height²
1-month
Nutrition intake level(%)
Time Frame: 0-month
Investigate the ratio of actual energy and protein intake levels to target intake levels
0-month
Nutrition intake level(%)
Time Frame: 1-month
Investigate the ratio of actual energy and protein intake levels to target intake levels
1-month
PG-SGA score
Time Frame: 0-month
Scored Patient-Generated Subjective Global Assessment(PG-SGA)：(0-1，stage A；2-8，stage B；≥9，stageC)
0-month
PG-SGA score
Time Frame: 1-month
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)
Time Frame: 0-month
Anorexia/Cachexia Sub-scale-12：score 0～24，Anorexia/Cachexia
0-month
Functional Assessment of Anorexia/Cachexia Therapy(FAACT)
Time Frame: 1-month
Anorexia/Cachexia Sub-scale-12：score 0～24，Anorexia/Cachexia
1-month
Survival rate(%)
Time Frame: 1-month
(Number of surviving cases after 1 month of follow-up)/(number of cases at the beginning of follow-up) ×100%
1-month
Survival rate(%)
Time Frame: 3-month
(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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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