Gastric cancer (in patients who underwent gastrectomy)
Conditions
Interventions
Implement exercise therapy and nutritional therapy.
Sponsors
Hiki Naoki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria at the time of registration. If it is determined after registration that any of these criteria are not met, the patient will be withdrawn from the study. 1) Aged 20 years or older and under 85 years at the time of registration 2) Patients diagnosed with gastric adenocarcinoma by histology. 3) Patients with cStage I to IVA who are expected to be eligible for curative (R0) resection. 4) PS: ECOG performance status score of 0-2. 5) Patients scheduled for elective surgery (type of procedure not restricted). 6) Patients must be able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients must meet the following criteria at the time of registration: If it is determined after registration that a patient meets any of these criteria, they will be removed from the study. 1) Patients with active, concurrent cancer 2) Patients with a history of gastric cancer treatment (excluding endoscopic treatment). 3) Patients undergoing preoperative chemotherapy. 4) Patients diagnosed with malnutrition according to the GLIM criteria prior to surgery. 5) Patients requiring emergency surgery 6) Patients with R1 or R2 resection on surgical findings. 7) Patients with any of the following severe complications prior to surgery: Heart: NYHA Class II or higher Lung: H-J Grade IV or higher Liver: Child classification B or higher, or Liver dysfunction grade B or higher AST >= 100 IU/L or ALT >= 100 IU/L. Total bilirubin >= 2.0 mg/dL Renal: Cr >= 1.5 mg/dL 8) Patients with activity limitations due to complications such as limb paralysis. 9) Patients with thrombosis 10) Patients with hypersensitivity to eggs, soybeans, or thiamine hydrochloride. 11) Patients are either injecting insulin or taking warfarin. 12) Patients taking oral nutritional supplements or supplements containing branched-chain amino acids (BCAAs). 13) Patients with mental disorders or dementia who are unable to provide informed consent 14) Other patients were deemed inappropriate for this study by the principal investigator or subinvestigator for reasons necessary for the safe conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the percentage change in lean body mass one month after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Evaluation within one year after surgery: -Differences in changes in fat-free body weight, body weight, body composition (skeletal muscle mass, muscle mass, and fat mass), and skeletal muscle index. -Differences in changes in gait speed , grip strength, knee extension strength, and the five-repetition sit-to-stand test. -Changes in nutritional indicators -Energy intake 2) Incidence of postoperative complications 3) Postoperative exercise compliance 4) Compliance with postoperative chemotherapy 5) Incidence of adverse events from postoperative chemotherapy 6) Evaluation at one, two, three, four, and five years postoperatively -Disease-free survival rate -Overall survival rate -Quality of life (QOL) assessment | — |
Contacts
Public ContactMikiko Sakuraya
Kitasato University School of Medicine l
Outcome results
None listed