Nutritional Intervention for Patients With Multiple Cancer Types

September 22, 2023 updated by: Kai Li, First Hospital of China Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interventian group
Intensive nutritional interventions based on real-world treatments
Dietary supplement: Nutritional therapy
Intensive nutritional therapy based on real world therapy
Experimental: control group
Nutritional guidance and education based on real world treatments
Dietary supplement: Nutritional therapy
Intensive nutritional therapy based on real world therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival index
Time Frame: 3 years
DFS/OS
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life index
Time Frame: 3years
Perioperative survival index of patients with multiple cancer types
3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Investigators

  • Study Director: Kai Li, MD, First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FirstHCMU_nutrient

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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