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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06059560
Other study ID # FirstHCMU_nutrient
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date October 1, 2026

Study information

Verified date September 2023
Source First Hospital of China Medical University
Contact Kai Li, MD
Phone 8613998245233
Email cmu1h_likai@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the nutritional status of patients with different types of tumors by continuous nutritional intervention and follow-up intervention in the perioperative period,and the impact on progression-free survival/survival and quality of life.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date October 1, 2026
Est. primary completion date October 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - ? Age =18 years old, <80 years old, male or female; ? The patient signed the informed consent and volunteered to participate in the study; ? Patients with malignant tumors (laryngeal cancer, esophageal cancer, lung cancer, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer) evaluated by clinical stage II to IV; ? Patients undergoing tumor surgery; ? Patients with NRS 2002 score = 3 after management risk screening; ? Basic reading and communication skills; ? Have the ability to act; Patients with a life expectancy greater than 6 months; Exclusion Criteria: - ? Acute onset of chronic disease; ? Pregnant or lactating women; ? Patients with contraindications and no tumor surgery; (4) Patients with malignant tumors (laryngeal cancer, esophageal cancer, lung cancer, stomach cancer, colorectal cancer, liver cancer, pancreatic cancer) were confirmed by pathology and/or cytology after surgery; ? Combined with cognitive dysfunction, mental disorder, consciousness disorder or unwillingness to cooperate; ? Patients with severe gastrointestinal symptoms, liver and renal insufficiency (alanine aminotransferase ALT=2 times the upper limit of normal value; Total bilirubin Tbil=2 times the upper limit of normal value; Creatinine Cr=2 times the upper limit of normal value); (7) Patients with two or more types of tumors; Long-term bed rest, hemiplegia or coma; ? Severe dysfunction of liver, kidney and other organs; ? Allergy or intolerance to nutrients or their main components (such as lactose or galactose, etc.).

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Nutritional therapy
Intensive nutritional therapy based on real world therapy

Locations

Country Name City State
China The First Affiliated Hospital of China Medical University Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival index DFS/OS 3 years
Secondary Quality of life index Perioperative survival index of patients with multiple cancer types 3years
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