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

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

NCT ID: NCT05856500

Condition: Stage IV Gastric Cancer
Stage IIIA Gastric Cancer
Stage IIIB Gastric Cancer
Stage III Esophageal Cancer
Stage IV Esophageal Cancer

Conditions: Official terms:
Stomach Neoplasms
Esophageal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Wasting Syndrome
Cachexia
Curcumin

Conditions: Keywords:
Creatine
Cur-cumin
Early Cachexia

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Dietary Supplement
Intervention name: basic nutrition
Description: An adequate supply of energy and protein in diet, oral nutrition supplement or tube feeding enteral nutrition supplement when diet is deficient.
Arm group label: basic nutrition

Intervention type: Dietary Supplement
Intervention name: oral supplement of creatine and curcumin
Description: Creatine and curcumin are orally added other than basic nutrition treatment.
Arm group label: oral supplement of creatine and curcumin

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Start date: June 1, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class: Other

Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05856500