Nutritional Intervention for Patients With Multiple Cancer Types

NCT ID: NCT06059560

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-10-01

Brief 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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

interventian group

Intensive nutritional interventions based on real-world treatments

Group Type: EXPERIMENTAL

Nutritional therapy

Intervention Type: DIETARY_SUPPLEMENT

Intensive nutritional therapy based on real world therapy

control group

Nutritional guidance and education based on real world treatments

Group Type: EXPERIMENTAL

Nutritional therapy

Intervention Type: DIETARY_SUPPLEMENT

Intensive nutritional therapy based on real world therapy

Interventions

Nutritional therapy

Intensive nutritional therapy based on real world therapy

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• ① Age ≥18 years old, <80 years old, male or female; ② The patient signed the informed consent and volunteered to participate in the study; ③ 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; ④ Patients undergoing tumor surgery; ⑤ Patients with NRS 2002 score ≥ 3 after management risk screening; ⑥ Basic reading and communication skills; ⑦ Have the ability to act; Patients with a life expectancy greater than 6 months;

Exclusion Criteria

• ① Acute onset of chronic disease; ② Pregnant or lactating women; ③ 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; ⑤ Combined with cognitive dysfunction, mental disorder, consciousness disorder or unwillingness to cooperate; ⑥ 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; ⑨ Severe dysfunction of liver, kidney and other organs; ⑩ Allergy or intolerance to nutrients or their main components (such as lactose or galactose, etc.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kai Li

Deputy Director of surgical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kai Li, MD

Role: STUDY_DIRECTOR

First Hospital of China Medical University

Locations

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kai Li, MD

Role: CONTACT

cmu1h_likai@163.com

8613998245233

Facility Contacts

Kai Li, MD

Role: primary

cmu1h_likai@163.com

+8613998245233

Other Identifiers

FirstHCMU_nutrient

Identifier Type: -

Identifier Source: org_study_id