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NCT06997302Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 30 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
150 (actual)
First submitted
3 Mar 2025
Start date
1 Jan 2022
Primary completion date
31 Dec 2023
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
NCT number
NCT06997302

What you commit to

  • Study type: Interventional
  • Participants enrolled: 150
  • From 1 Jan 2022 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • Pregnant individuals;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tianjin Medical University Cancer Institute and Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.