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A single-center, single-arm study on the effect of enteral nutrition on the degree of chemotherapy completion after surgery for gastric cancer

A single-center, single-arm study on the effect of enteral nutrition on the degree of chemotherapy completion after surgery for gastric cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040455
Enrollment
Unknown
Registered
2020-11-28
Start date
2021-07-01
Completion date
Unknown
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Case series:Enteral nutritional preparations should be used every day after surgery

Sponsors

The First Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Postoperative pathology identified the patients as advanced stage (stage II and III); 3. Subject is malnourished or at risk of malnutrition (nutritional risk screening tool 2002 (nrs-2002) >=3 points); 4. Adjuvant chemotherapy is expected after surgery; 5. Laboratory tests were tolerant to surgery and chemotherapy; 6. Subject's life expectancy >=12 months; 7. Written informed consent can be obtained prior to randomization, and the patient should be aware that he or she has the right to withdraw from the study at any time without prejudice to subsequent treatment; 8. Subjects are willing to comply with the study protocol and are able and willing to ingest the study products according to the protocol; 9. Female subjects were not pregnant or at least 6 weeks postpartum and did not breastfeed.When screening, pregnant women of childbearing age should be examined to make sure there is no pregnancy; 10. Consent to provide hematological specimens.

Exclusion criteria

Exclusion criteria: 1. Subjects are not at risk of malnutrition or malnutrition (nutritional risk screening tool 2002 (NRS-2002) <3 points); 2. Postoperative patients are expected to be without chemotherapy; 3. Pregnant or nursing women; 4. For patients with uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator shall determine whether the clinical severity of the disorder impedes the signing of informed consent or affects the patient's oral medication compliance; 5. If the subject has abnormal liver function or renal function, the doctor thinks that the subject cannot participate in the test; 6. The subject has severe cardiac insufficiency and is considered by the doctor to be unable to participate in the study; 7. Subjects have type 1 or type 2 diabetes (based on history and admission diagnosis, according to the study physician's opinion); 8. During the previous week, subjects had severe nausea, vomiting, and/or uncontrollable diarrhea/celiac dysentery (based on reported history or from the opinion of the study physician); 9. Subjects have a known history of dementia, brain metastases, eating disorders, significant neurological or psychiatric disorders, or have received antipsychotic treatment as a result of a mental illness statement; 10. The subject is known to have a history of allergy or intolerance to any ingredient in the test product; 11. Subjects are currently participating in or have participated in any other clinical trial.

Design outcomes

Primary

MeasureTime frame
Degree of completion of chemotherapy;

Secondary

MeasureTime frame
BMI;NRS2002;progression free survival;overall survival;

Countries

China

Contacts

Public ContactYin Kai

The First Affiliated Hospital of Naval Medical University

kyin67@126.com+86 13901934198

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026