Nutritional Intervention for Patients With Multiple Cancer Types

Cancer Clinical Trial

Official title:

An Open, Real-world Study of the Effects of Perioperative Intensive Nutritional Management on Short-term Quality of Life and Long-term Life Outcomes in Patients With Multiple Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059560
• Other study ID #: FirstHCMU_nutrient
• Status: Recruiting
• Phase: N/A
• 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
• 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.).

Related Conditions & MeSH terms

• Cancer

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