Nutritional Intervention for Patients With Multiple Cancer Types

Sponsor

First Hospital of China Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06059560

Collaborator

(none)

1,000

Enrollment

Location

Arms

Anticipated Duration (Months)

27.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Dietary Supplement: Nutritional therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Survival index [3 years]
DFS/OS

Secondary Outcome Measures

Quality of life index [3years]
Perioperative survival index of patients with multiple cancer types

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China

Sponsors and Collaborators

First Hospital of China Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kai Li, Deputy Director of surgical Oncology, First Hospital of China Medical University

ClinicalTrials.gov Identifier:

NCT06059560

Other Study ID Numbers:

FirstHCMU_nutrient

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kai Li, Deputy Director of surgical Oncology, First Hospital of China Medical University

nutrition

prognosis

Study Results

No Results Posted as of Sep 28, 2023