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

Primary Purpose

Stage IV Gastric Cancer, Stage IIIA Gastric Cancer, Stage IIIB Gastric Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
basic nutrition
oral supplement of creatine and curcumin
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Gastric Cancer focused on measuring Creatine, Cur-cumin, Early Cachexia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    basic nutrition

    oral supplement of creatine and curcumin

    Arm Description

    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;

    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.

    Outcomes

    Primary Outcome Measures

    L3 skeletal muscle index(c㎡/㎡)
    CT scans L3 cross-sectional skeletal muscle area/height²
    L3 skeletal muscle index(c㎡/㎡)
    CT scans L3 cross-sectional skeletal muscle area/height²
    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.
    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.

    Secondary Outcome Measures

    Pre-albumin concentration(mg/L)
    Serological pre-albumin concentration
    Pre-albumin concentration(mg/L)
    Serological pre-albumin concentration
    Albumin concentration(g/L)
    Serological albumin concentration
    Albumin concentration(g/L)
    Serological albumin concentration
    Body Mass Index(kg/㎡)
    body weight/height²
    Body Mass Index(kg/㎡)
    body weight/height²
    Nutrition intake level(%)
    Investigate the ratio of actual energy and protein intake levels to target intake levels
    Nutrition intake level(%)
    Investigate the ratio of actual energy and protein intake levels to target intake levels
    PG-SGA score
    Scored Patient-Generated Subjective Global Assessment(PG-SGA)：(0-1，stage A；2-8，stage B；≥9，stageC)
    PG-SGA score
    Scored Patient-Generated Subjective Global Assessment(PG-SGA)：(0-1，stage A；2-8，stage B；≥9，stageC)
    Functional Assessment of Anorexia/Cachexia Therapy(FAACT)
    Anorexia/Cachexia Sub-scale-12：score 0～24，Anorexia/Cachexia
    Functional Assessment of Anorexia/Cachexia Therapy(FAACT)
    Anorexia/Cachexia Sub-scale-12：score 0～24，Anorexia/Cachexia
    Survival rate(%)
    (Number of surviving cases after 1 month of follow-up)/(number of cases at the beginning of follow-up) ×100%
    Survival rate(%)
    (Number of surviving cases after 3 month of follow-up)/(number of cases at the beginning of follow-up) ×100%

    Full Information

    First Posted
    December 5, 2022
    Last Updated
    May 16, 2023
    Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05856500
    Brief Title
    A Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors
    Official Title
    A Prospective Open Controlled Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stage IV Gastric Cancer, Stage IIIA Gastric Cancer, Stage IIIB Gastric Cancer, Stage III Esophageal Cancer, Stage IV Esophageal Cancer
    Keywords
    Creatine, Cur-cumin, Early Cachexia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    152 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    basic nutrition
    Arm Type
    Placebo Comparator
    Arm Description
    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;
    Arm Title
    oral supplement of creatine and curcumin
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    basic nutrition
    Intervention Description
    An adequate supply of energy and protein in diet, oral nutrition supplement or tube feeding enteral nutrition supplement when diet is deficient.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    oral supplement of creatine and curcumin
    Intervention Description
    Creatine and curcumin are orally added other than basic nutrition treatment.
    Primary Outcome Measure Information:
    Title
    L3 skeletal muscle index(c㎡/㎡)
    Description
    CT scans L3 cross-sectional skeletal muscle area/height²
    Time Frame
    0-month
    Title
    L3 skeletal muscle index(c㎡/㎡)
    Description
    CT scans L3 cross-sectional skeletal muscle area/height²
    Time Frame
    1-month
    Title
    Appendicular skeletal muscle mass index(kg/㎡)
    Description
    Appendicular skeletal muscle mass(ASM)is measured by bioelectrical impedance analysis(BIA), the ASM index (ASM/height²)is calculated.
    Time Frame
    0-month
    Title
    Appendicular skeletal muscle mass index(kg/㎡)
    Description
    Appendicular skeletal muscle mass(ASM)is measured by bioelectrical impedance analysis(BIA), the ASM index (ASM/height²)is calculated.
    Time Frame
    1-month
    Secondary Outcome Measure Information:
    Title
    Pre-albumin concentration(mg/L)
    Description
    Serological pre-albumin concentration
    Time Frame
    0-month
    Title
    Pre-albumin concentration(mg/L)
    Description
    Serological pre-albumin concentration
    Time Frame
    1-month
    Title
    Albumin concentration(g/L)
    Description
    Serological albumin concentration
    Time Frame
    0-month
    Title
    Albumin concentration(g/L)
    Description
    Serological albumin concentration
    Time Frame
    1-month
    Title
    Body Mass Index(kg/㎡)
    Description
    body weight/height²
    Time Frame
    0-month
    Title
    Body Mass Index(kg/㎡)
    Description
    body weight/height²
    Time Frame
    1-month
    Title
    Nutrition intake level(%)
    Description
    Investigate the ratio of actual energy and protein intake levels to target intake levels
    Time Frame
    0-month
    Title
    Nutrition intake level(%)
    Description
    Investigate the ratio of actual energy and protein intake levels to target intake levels
    Time Frame
    1-month
    Title
    PG-SGA score
    Description
    Scored Patient-Generated Subjective Global Assessment(PG-SGA)：(0-1，stage A；2-8，stage B；≥9，stageC)
    Time Frame
    0-month
    Title
    PG-SGA score
    Description
    Scored Patient-Generated Subjective Global Assessment(PG-SGA)：(0-1，stage A；2-8，stage B；≥9，stageC)
    Time Frame
    1-month
    Title
    Functional Assessment of Anorexia/Cachexia Therapy(FAACT)
    Description
    Anorexia/Cachexia Sub-scale-12：score 0～24，Anorexia/Cachexia
    Time Frame
    0-month
    Title
    Functional Assessment of Anorexia/Cachexia Therapy(FAACT)
    Description
    Anorexia/Cachexia Sub-scale-12：score 0～24，Anorexia/Cachexia
    Time Frame
    1-month
    Title
    Survival rate(%)
    Description
    (Number of surviving cases after 1 month of follow-up)/(number of cases at the beginning of follow-up) ×100%
    Time Frame
    1-month
    Title
    Survival rate(%)
    Description
    (Number of surviving cases after 3 month of follow-up)/(number of cases at the beginning of follow-up) ×100%
    Time Frame
    3-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaotian Chen
    Phone
    13851752678
    Email
    chenxiaotian@njglyy.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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