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

NCT ID: NCT05856500

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-12-31

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.

Conditions

Stage IV Gastric Cancer; Stage IIIA Gastric Cancer; Stage IIIB Gastric Cancer; Stage III Esophageal Cancer; Stage IV Esophageal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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;

Group Type: PLACEBO_COMPARATOR

basic nutrition

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: EXPERIMENTAL

oral supplement of creatine and curcumin

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

basic nutrition

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

oral supplement of creatine and curcumin

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xiaotian Chen

Role: CONTACT

chenxiaotian@njglyy.com

13851752678

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2022-223-02

Identifier Type: -

Identifier Source: org_study_id