Nutritional Intervention for Patients With Multiple Cancer Types

NCT06059560 | Recruiting

• 1 other identifier: FirstHCMU_nutrient
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

nutrition; prognosis

Outcome Measures

Primary Outcomes (1)

• Survival index

  DFS/OS

  3 years

Secondary Outcomes (1)

• Quality of life index

  3years

Study Arms (2)

interventian group

EXPERIMENTAL

Intensive nutritional interventions based on real-world treatments

Dietary Supplement: Nutritional therapy

control group

EXPERIMENTAL

Nutritional guidance and education based on real world treatments

Dietary Supplement: Nutritional therapy

Interventions

Nutritional therapy DIETARY_SUPPLEMENT

Intensive nutritional therapy based on real world therapy

control group; interventian group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.).

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Nutrition Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Kai Li, MD

  First Hospital of China Medical University

  STUDY DIRECTOR

Central Study Contacts

Kai Li, MD

CONTACT

8613998245233; cmu1h_likai@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of surgical Oncology

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CN (1)