Gastric cancer
Conditions
Interventions
Replace regular meals with formula meals 3 Group
once daily replacement, twice daily, three times daily
Sponsors
Gastric Surgery, Department of Gastroenterological Surgery, The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Sunnyhealth Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Gastric adenocarcinoma is diagnosed histologically. 2) Patients must have cStage I-III gastric cancer that is expected to be amenable to radical (R0) resection. 3) Male and female patients aged 20 years or older but less than 80 years at the time of enrollment. 4) Body mass index of 25 kg/m2 or more. 5) PS: ECOG performance status score 0-2. 6) Patients are scheduled to undergo elective surgery. 7) Patients must be free of complications such as tetraplegia and have no limitation of activity. 8) Patients have not been previously treated for gastric cancer. However, endoscopic treatment is acceptable. 9) No preoperative treatment for gastric cancer. 10) Main organ function is preserved and the patient is judged to be operable. 11) Informed consent to participate in the study has been obtained from the patient.
Exclusion criteria
Exclusion criteria: None of the following apply. 1) The patient is scheduled to undergo simultaneous resection for multiple cancers. 2) The patient has preoperative severe malnutrition or requires preoperative tube feeding. 3) The patient is undergoing emergency surgery. 4) The patient has been diagnosed with dementia. 5) The patient has psychosis or psychiatric symptoms. 6) Patient has a history of allergy to formula diets. 7) Patient is taking oral nutritional supplements or supplements. 8) Patient has a condition that the study physician deems inappropriate. 9) Patient does not give consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of weight loss program completed | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of adverse events in the weight loss program, weight change before and after the intervention, changes in body composition, rate of weight loss and changes in body composition (lean body mass, fat mass) at 1, 3, and 6 months after surgery, energy and protein intake per week from the intervention, incidence of postoperative complications, operating time, intraoperative blood loss, prealbumin levels before and after intervention, postoperative inflammatory status | — |
Countries
Japan
Contacts
Public ContactRyota Matsui
The Cancer Institute Hospital of Japanese Foundation for Cancer Research Gastric Surgery, Department of Gastroenterological Surgery
Outcome results
None listed