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

Nanjing University

Status: Not yet enrolling

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

Treatments: Dietary Supplement: basic nutrition; Dietary Supplement: oral supplement of creatine and curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT05856500

2022-223-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups, including a placebo group

basic nutrition

Placebo Comparator group

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;

Treatment:

Dietary Supplement: basic nutrition

oral supplement of creatine and curcumin

Experimental group

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.

Treatment:

Dietary Supplement: oral supplement of creatine and curcumin