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NCT Number: NCT06997302

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Nutritional Supplement

Other

Dietary nutrition guidance.

Primary outcomes

  1. European Nutritional Risk Screening (NRS) 2002 scores

    Time frame: 9 weeks

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

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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