Stage III Gastric Cancer Clinical Trial
— CRUCIALOfficial title:
The Effects of Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer on Long-term Disease-free Survival After Total Gastrectomy in Patients With Stage III Gastric Cancer
NCT number | NCT05253716 |
Other study ID # | 2021-12-4 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2022 |
Est. completion date | March 2026 |
Gastric cancer patients with stage III will be randomized to immune nutrition support or control group at discharge after total gastrectomy. Patients will receive 6 months of immune nutrition support or normal diet after discharge. The primary and secondary outcomes will be collected.
Status | Recruiting |
Enrollment | 696 |
Est. completion date | March 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Informed consent of patients or their legal representatives to participate in this study 2. consecutive adult (=18 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III 3. nutrition Risk Screening (NRS) 2002=3 at discharge 4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge Exclusion Criteria: 1. unable to oral or consume ONS 2. has received neoadjuvant chemotherapy 3. pregnancy 4. palliative surgery or gastric stump cancer or Borrmann type IV 5. oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease 6. serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension 7. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia 8. diabetes has developed complications or uncontrolled by medications 9. previous use of drugs affecting immune function 10. previous use of fish oil capsule > 2 times / week or contraindications to fish oil capsule 11. motor system diseases cannot complete grip strength measurement and 5-time chair stand test |
Country | Name | City | State |
---|---|---|---|
China | Jinling Hospital, China | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jinling Hospital, China | ChangZhou Second hospital, Nanjing Jiangning Hospital, Second Affiliated Hospital of Soochow University, The Affiliated cancer hospital of Nanjing Medical University, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, The Second Hospital of Nanjing Medical University, The Third Affiliated Hospital of Soochow University, Wuxi People's Hospital, Yixing People's Hospital, Zhenjiang First People's Hospital |
China,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-year disease free survival after discharge | from date of randomization to disease recurrence or death | up to 3 years | |
Secondary | 3-year overall survival | from date of randomization to death due to any reason, | up to 3 years. | |
Secondary | unplanned readmission rate | readmission due to unplanned reason | up to 6 months. | |
Secondary | Quality of life after discharge | Quality of life assessed by EORTC QLQ-C30 | up to 12 months. | |
Secondary | incidence of sarcopenia after discharge | sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability. | up to 12 months. | |
Secondary | Changes in BMI (weight and height will be combined to report BMI in kg/m^2) | nutritional status after discharge | up to 12 months. | |
Secondary | Changes in albumin level | nutritional status after discharge | up to 12 months. | |
Secondary | Changes in prealbumin level | nutritional status after discharge | up to 12 months. | |
Secondary | Changes in hemoglobin level | nutritional status after discharge | up to 12 months. | |
Secondary | Changes in weight | nutritional status after discharge | up to 12 months. | |
Secondary | toxicity of chemotherapy graded according to the CTCAE, version 5.0 | Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0. | up to 6 months. |
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