Clinical trial NCT05856500: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: L3 skeletal muscle index(c㎡/㎡)
timeFrame: 0-month
measure: L3 skeletal muscle index(c㎡/㎡)
timeFrame: 1-month
measure: Appendicular skeletal muscle mass index(kg/㎡)
timeFrame: 0-month
measure: Appendicular skeletal muscle mass index(kg/㎡)
timeFrame: 1-month
Secondary outcomes:
measure: Pre-albumin concentration(mg/L)
timeFrame: 0-month
measure: Pre-albumin concentration(mg/L)
timeFrame: 1-month
measure: Albumin concentration(g/L)
timeFrame: 0-month
measure: Albumin concentration(g/L)
timeFrame: 1-month
measure: Body Mass Index(kg/㎡)
timeFrame: 0-month
measure: Body Mass Index(kg/㎡)
timeFrame: 1-month
measure: Nutrition intake level(%)
timeFrame: 0-month
measure: Nutrition intake level(%)
timeFrame: 1-month
measure: PG-SGA score
timeFrame: 0-month
measure: PG-SGA score
timeFrame: 1-month
measure: Functional Assessment of Anorexia/Cachexia Therapy(FAACT)
timeFrame: 0-month
measure: Functional Assessment of Anorexia/Cachexia Therapy(FAACT)
timeFrame: 1-month
measure: Survival rate(%)
timeFrame: 1-month
measure: Survival rate(%)
timeFrame: 3-month
Other outcomes:
Locations:
Study officials:
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