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

NCT05856500 | Unknown

• 1 other identifier: 2022-223-02
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Pre-albumin concentration(mg/L)

  0-month

• Pre-albumin concentration(mg/L)

  1-month

• Albumin concentration(g/L)

  0-month

• Albumin concentration(g/L)

  1-month

• Body Mass Index(kg/㎡)

  0-month

Study Arms (2)

basic nutrition

PLACEBO COMPARATOR

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

oral supplement of creatine and curcumin

EXPERIMENTAL

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

Interventions

basic nutrition DIETARY_SUPPLEMENT

An adequate supply of energy and protein in diet, oral nutrition supplement or tube feeding enteral nutrition supplement when diet is deficient.

basic nutrition

oral supplement of creatine and curcumin DIETARY_SUPPLEMENT

Creatine and curcumin are orally added other than basic nutrition treatment.

oral supplement of creatine and curcumin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms; Cachexia

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Central Study Contacts

Xiaotian Chen

CONTACT

13851752678; chenxiaotian@njglyy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: May 12, 2023
• Study Start: June 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 18, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share