A Study on the Impact of Intelligent Nutrition Management on Clinical Outcomes in Chemotherapy Patients With Gastrointestinal Malignancies

NCT06997302 | Active Not Recruiting

• 1 other identifier: TJMUCH-GI-ST01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

An increasing body of evidence suggests that nutritional status is a key factor in determining the quality of life of cancer patients. The sensitivity of cancer patients to anti-tumor treatments, the occurrence of side effects, and their quality of life are closely related to their nutritional status. Data show that about 50% of cancer patients experience a weight loss of more than 10% at the time of diagnosis and treatment, and once patients enter a cachexia state, the weight loss becomes difficult to reverse. Therefore, the extent to which nutritional interventions can impact clinical outcomes in these patients needs to be answered through clinical research. Currently, there are few studies using randomized controlled trials (RCTs) to explore how nutritional interventions can improve patients' quality of life, particularly in terms of prolonging survival. A recent RCT in a smaller sample population found that long-term, intensive, individualized nutritional counseling and support not only improved malnutrition in cancer patients, reduced treatment complications, and enhanced quality of life but also significantly extended survival time. This study is a prospective, randomized controlled clinical trial aimed at investigating the effect of full-scale intelligent nutrition management in gastrointestinal malignancy patients (esophageal cancer, gastric cancer) undergoing chemotherapy. The study attempts to confirm that full-scale intelligent nutrition management can benefit these patients by maintaining or improving their nutritional status, and that the clinical effectiveness of intelligent nutrition management is comparable to that of professional nutritionists. This research will also provide clinical evidence for the intelligent and standardized nutritional treatment of cancer patients during the chemotherapy period.

Conditions

Gastric (Stomach) Cancer; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• European Nutritional Risk Screening (NRS) 2002 scores

  NRS2002 scores for participants in all groups after 9-week nutritional intervention.

  9 weeks

Study Arms (3)

Control group.

NO INTERVENTION

In the Control group, necessary nutritional support or dietary guidance were provided by clinical physicians following standard clinical procedures.

Study group 1

EXPERIMENTAL

In Research Group 1, nutritional status was assessed using a clinical nutrition analyzer, with interventions tailored to the system-generated "Nutritional Diagnosis Report" and recommendations.

Other: Nutritional Supplement

Study group 2

EXPERIMENTAL

Patients in Research Group 2 underwent evaluation by a multidisciplinary team comprising clinical physicians and dietitians, who collaboratively designed and delivered nutritional support.

Other: Nutritional Supplement

Interventions

Nutritional Supplement OTHER

Dietary nutrition guidance.

Study group 1; Study group 2

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years;
• Voluntarily agree to participate and sign the informed consent form;
• Diagnosed with gastrointestinal malignancy (esophageal cancer, gastric cancer) and planned to undergo chemotherapy;
• Physical activity is acceptable, and capable of undergoing body composition analysis.

You may not qualify if:

• Uncontrolled or severe heart, liver, lung, and kidney diseases;
• History of stroke, epilepsy, or primary brain cancer, or patients with brain metastases from cancer;
• Pregnant individuals;
• Individuals allergic to milk, whey protein, etc.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: May 30, 2025
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-03

Locations

CN (1)